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November 2018 Volume 10  Issue 11 PHARMACYNEWSIRELAND.COM

THE INDEPENDENT VOICE OF PHARMACY

In this issue: NEWS: Pharmacists welcome cut in Drugs Payment Scheme threshold Page 4

NEWS: Role of pharmacists key to successful self-care strategy Page 5

NEWS: Row over proposed change in role of pharmaceutical assistants rumbles on Page 12

REPORT: Majority of pharmacists not ready for Falsified Medicines Directive Page 21

NEWS: Manifesto calls for Ireland to be at forefront of access to new medicines Page 38

CPD: Medicines optimisation in care homes Page 39

FEATURE: Contraception Page 48 PHARMACYNEWSIRELAND.COM | 1


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Foreword

Contents

The row over The Pharmaceutical Society of Ireland (PSI) proposals that will change the work practices of pharmaceutical assistants, and will limit their ability to cover for absent pharmacists, rumbles on in November’s packed edition of Irish Pharmacy News.

Page 6: Pharmacists and GPs call for phasing out of ¤2 medical card prescription levy

Page 16: Spot the difference between cold and flu

6

Page 18: Concerns over dispensing of anticonvulsant medication Page 30: Legislation suggests pharmacists will have no role in abortion services

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Page 66: Real Deal conference PUBLISHER IPN Communications Ireland Ltd. Clifton House, Fitzwilliam Street Lower, Dublin 2 00353 (01) 6690562 MANAGING DIRECTOR Natalie Maginnis n-maginnis@btconnect.com

66

EDITOR Jonny McCambridge editorial@ipnirishpharmacynews.ie

ADVERTISING SALES Louie French / Tina Hall 00353 (1) 6690562

Irish Pharmacy IRISH News is circulated PHARMACY NEWS to all independent, multiple and hospital Pharmacists and academics in Ireland.

All rights reserved by Irish Pharmacy News. All material published in Irish Pharmacy News is copyright and no part of this magazine may be reproduced, stored in a retrieval system or transmitted in any form without written PHARMACYNEWSIRELAND.COM permission. IPN Communications Ltd. has taken every care in compiling the magazine @Irish_PharmNews to ensure that it is correct at the time of going to press, however the publishers assume no responsibility for any effects from omissions IrishPharmacyNews or errors.

CONTRIBUTORS Amanda Phelan | Andrew Jennings Kevin Doherty | Amy Louise Oates

Regulars

Meanwhile our November edition also features the latest in our series of special reports on the preparations pharmacists are making the for the introduction of the Falsified Medicines Directive (FMD), which is set to be introduced across the EU next year. Alarmingly an online poll carried out by IPN delivered concerning results. Sixty-five percent of respondents said their community pharmacy team is “neither informed nor prepared” for the upcoming February 2019 compliance deadline.

Page 56: Four in five are disposing of medication inappropriately

ADVERTISING DIRECTOR Debbie Graham debbie@ipn.ie

An online poll carried out by Pharmabuddy.ie found that almost 90% of those who responded were opposed to the new rules. Pharmacists contacted by IPN have told a similar story with concerns raised over how the change will work in practice and warnings of potential legal action. IPN will continue to follow the story as it develops.

PROFILE FEATURE REFLUX AND MILK ALLERGIES

9 14

It is clear that as the date for the introduction of FMD approaches much work is still needed to be carried out by regulators to ensure that pharmacists are ready for an important directive which could have significant changes for the way that many in the profession carry out their business. Leonie Clarke of the Irish Medicines Verification Organisation (IMVO) told us about what preparations are being made. She said: “We are very busy and it has turned out across Europe to be far more complicated than anyone had previously envisaged, and that applies to every aspect of it. The complications are not arising so much on the pharmacy side, but more so from the point of view of manufacturers getting their systems connected and their data uploaded.” Also in this month’s edition pharmacists respond to the budget. While the decision to reduce the prescription levy to ¤1.50 per item for the over 70s is welcome it is clear that more needs to be done. The Government needs to consider removing the levy in its entirety especially for those in vulnerable patient groups, such as homeless people, those in residential care settings, patients with intellectual disabilities and palliative care patients. November’s edition of IPN also features the usual wide array of features, reports and clinical articles. Do you have a news tip? Is there a community pharmacist topic you would like to see featured in Irish Pharmacy News? Do you know someone in the business who is going the extra mile to promote best practice in Irish community pharmacy? Email editorial@irishpharmacynews.ie FEATURE CROHN’S DISEASE

24

FEATURE CONTRACEPTION

48

CPD

39

CLINICAL PROFILES

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Check out our article in this issue to learn how to increase your margin in these areas: 1. 2. 3. 4. 5. 6.

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News Pharmacists welcome budget cut in news brief Drugs Payment Scheme threshold FURTHER IMPURITIES FOUND IN VALSARTAN Following a recall of medicines containing valsartan due to the presence of a probable human carcinogen, German regulators have detected low levels of another nitrosamine, N-nitrosodiethylamine (NDEA), in one batch of losartan manufactured in India by Hetero Labs. Like NDMA, which was the initial impurity that was found in valsartan products, NDEA is formed from a specific sequence of manufacturing steps and chemical reactions. The US regulator, the FDA, is continuing to test all valsartancontaining products for NDEA and other impurities. In addition to testing, the FDA will share its methodology for detecting NDEA with manufacturers and global regulators for use when screening other products that might contain human carcinogens.

PHARMACY PAYS COMPENSATION TO ALGERIAN MAN An Algerian man, who was questioned by staff in a Boots pharmacy when he tried to purchase a small a quantity of hydrogen peroxide, has been awarded compensation by the Workplace Relations Commission (WRC). The man, who was purchasing the supplies on behalf of his wife, says he was made to feel “uncomfortable and embarrassed about being questioned about an over-the-counter product that he used in his house.” Representatives for Boots Retail (Ireland) claimed staff are obliged to question anyone who appeared to be making a suspicious purchase, as defined in the regulations. Hydrogen peroxide is listed by the EU as an explosive precursor. The WRC adjudicator said the regulation does not apply to the sale of hydrogen peroxide in concentration levels at or below 12 percent and the product being purchased by the man in question was at a concentration level of 6 percent. The man claimed to have been discriminated against because of his beard and the colour of his skin. Boots Retail (Ireland) denied the claims and the man was awarded ¤700 in compensation for discrimination.

The Irish Pharmacy Union (IPU), which represents over 2,200 pharmacists across the country, has welcomed the decision to reduce the prescription levy to €1.50 per item for the over 70s, but continues to call for it to be removed in its entirety especially for those in vulnerable patient groups, such as homeless people, those in residential care settings, patients with intellectual disabilities and palliative care patients. The IPU also welcomed the ¤10 fall in the Drugs Payment Scheme (DPS) threshold to ¤124 from ¤134 announced in the Budget, but expressed disappointment that a more meaningful reduction was not announced. Daragh Connolly, President of the IPU, said, “While a prescription charge of ¤1.50 may seem insignificant, it is important to remember this is a charge on the healthcare of the vulnerable in our society. The Budget, has clearly demonstrated our economy has recovered to a point where we don’t need such blunt and unfair taxes.” The damaging health impact of this levy on many vulnerable patients was highlighted in the findings of a national Behaviour & Attitudes Survey carried out in April. According to Mr Connolly

this found, “that one in six Medical Card holders would ‘think twice’ about taking their prescribed medicines because of the cost of this levy. The number one priority for any patient, particularly those with long term conditions, must be on getting better. However, the continuation of this levy will ensure that unfortunately many will have to focus on finance instead.” Mr Connolly also said that while “the ¤10 reduction in the DPS threshold is welcome, it is clearly not enough to have a significant impact on hard pressed families. The Government should set out a roadmap to significantly reduce this threshold to a more bearable level over the next number of Budgets.” Mr Connolly concluded by criticising the continued failure to

introduce a Minor Ailment Scheme in pharmacies. “The failure to introduce a nationwide Minor Ailments Scheme is a missed opportunity for the tax payer, the health system and most of all the patient. This would involve enabling medical card patients to receive treatment for common illnesses, free of charge, directly from their local community pharmacy in a timely manner and without the need to pay for a visit to the GP. The introduction of a pharmacy-based Minor Ailment Scheme would save nearly 950,000 GP consultations every year, ensuring that this investment would serve patients with more complex cases. The IPU has already piloted this scheme with the HSE but has received no indication on when it will be rolled out.”

Pharmacists warn new rule could cost hundreds of jobs New rules which will change the time period in which a chemist can be temporarily absent from their pharmacy could see pharmaceutical assistants losing their jobs or having their working hours reduced, according to the Irish Pharmaceutical Union (IPU). A statement from the IPU said that the move will affect hundreds of pharmaceutical assistants across the country. The IPU said: "These exceedingly restrictive draft rules effectively render the pharmaceutical assistant qualification next-to-worthless and put at grave risk the continuing employment and employability of the remaining cohort of pharmaceutical assistants, most of whom have decades of practical experience and have accumulated significant experiential learning." Fine Gael Senator, Maria Byrne As revealed in IPN last month the Pharmaceutical Society of Ireland is proposing the new rules. Pharmaceutical Assistants work under a licensed pharmacist in a variety of medical and healthcare settings, such as hospitals, retail pharmacies and nursing homes and their responsibilities range from customer service duties to mixing and dispensing medication.

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Fine Gael Senator Maria Byrne said: “The Temporary Absence of Pharmacist from Pharmacy Rules 2018 will set out the arrangements under which pharmaceutical assistants may act in the temporary absence of a registered pharmacist restricting their hours to 12 hours per week. "Under the current framework pharmacy assistants can cover a pharmacist’s day off, short absence and up to two weeks’ holidays.

"The majority of pharmacy assistants are women over 50 years old. The last qualification for these positions was awarded in the 1980s." The Pharmaceutical Association of Registered Pharmaceutical Assistants said it will have a massive impact on the whole industry. In a statement it said: "The Pharmaceutical Society of Ireland Council approved rules that will restrict the work practices of pharmaceutical assistants. "If the new rules are signed into law by the Minister for Health, pharmaceutical assistants will no longer be able to provide professional cover for pharmacists’ day off. "In addition, 248 pharmaceutical assistants will be deprived of their right to earn a livelihood, having worked in pharmacies dispensing medication for customers for over 35 years." • See page 12


News Pharmacists key to driving successful selfcare strategy The role of community pharmacists is pivotal to the successful development of self-care and its more widespread adoption, according to the Irish Pharmacy Union (IPU) and the Irish Pharmaceutical Healthcare Association (IPHA). The two organisations have jointly launched a new self-care awareness campaign, entitled ‘Be Well this Winter – Think Pharmacy’. The campaign will be rolled out through the extensive deployment of social media, as well as a series of posters to be displayed nationwide in retail pharmacies. This campaign builds on the previously highly successful IPU/ IPHA joint initiative launched earlier this year, ‘Self Care: taking charge of your health’, which placed a major emphasis on the role of the pharmacist as a key component in helping people to manage their own health. Self-care is a healthcare philosophy which emphasises the role of ordinary people in taking ownership of their health and wellbeing and includes taking actions to prevent and decrease the likelihood of disease and to restore health after illness or injury. It is the first step and first choice for Irish people who are taking an increasingly active role in their healthcare and looking to improve their health and wellbeing.

Research from Behaviour & Attitudes confirms that there is a clear desire from the majority of people (92%) to be involved in decisions about their own health and medication, with 80% expressing their view that they see their pharmacist as a key partner in maintaining their health. Daragh Connolly, President of the Irish Pharmacy Union, said, “Promoting increased levels of self-care in Ireland would lead to a far more efficient and effective system of healthcare. Embracing a philosophy of self care can lead to real, measurable savings in healthcare expenses and better outcomes for patients and pharmacists can play a critical role in this area. Allowing pharmacists to work to their full scope will help to deliver better patient outcomes, by utilising our accessibility and professional capabilities to benefit patients, in partnership with our healthcare colleagues and the pharmaceutical industry.” Dave Barrett, Chairman of the Irish Pharmaceutical Healthcare Association, said, “As well as the obvious benefits for individuals in

CANCER WARNINGS TO APPEAR ON LABELS WITH THE PASSING OF THE ALCOHOL BILL Following years of intense debate, it has been confirmed that cancer warnings will appear on alcohol labels after the Public Health (Alcohol) Bill passed all legislative stages in the Dáil, almost three years after it was introduced by then Minister for Health, Leo Varadkar.

Dave Barrett, Chairman, Irish Pharmaceutical Healthcare Association

taking a greater role in maintaining healthy lives, adoption of self care principles could also help the State manage the financial challenges of an ageing population and strained healthcare budgets. As people take care of their own health and self-treatable conditions, more healthcare resources can be used for patients with severe and chronic diseases. Our industry is committed to working with healthcare professionals, especially pharmacists who are often the first port of call for health information and advice, to support consumers to identify the most appropriate channel within the healthcare system.”

HIQA's work on the introduction of a PrEP programme welcomed The HIQA has announced that they are looking at the feasibility of the government launching a a Pre-Exposure Prophylaxis (PrEP) programme in Ireland. The Health Information Quality Authority was asked by the Government to carry out a Health Technology Assessment to establish the clinical- and costeffectiveness of providing a PrEP programme in Ireland. The Minister for Health Simon Harris is committed to rolling out the PrEP programme in 2019, as outlined in The National Sexual Health Strategy 2015–2020, and considerable work has already been completed by the HSE to prepare for the introduction of a PrEP programme that meets appropriate standards. Minister Harris said: "We know that enormous progress has been made in the treatment of people living with HIV. However, we are also acutely aware of the significant numbers of people in Ireland being diagnosed.

"Prevention is absolutely essential and as Minister for Health I am keen to make PrEP, which is a prevention tool, more readily available to those at risk of HIV in Ireland." Commenting on the news, Paul Neill, Associate Director, Teva Pharmaceuticals Ireland said: “It is very welcome news that HIQA is looking at the financial and practical feasibility of the government launching a publicly funded PrEP (Pre Exposure Prophylaxis) programme in 2019. “Teva Ireland have been a leading voice in the need for such a programme. As a manufacturer of a drug which can reduce the risk of contracting HIV significantly, and a current supplier to community pharmacies across the country, we are encouraged by this announcement by HIQA. We hope that HIQA’s work in establishing

news brief

the clinical, and cost effectiveness of providing a PrEP programme in Ireland leads to a national PrEP programme. “There are over 500 new cases of HIV in Ireland each year, this indicates that there is a very real need for a proactive approach by government to ensure that all preventative strategies in combating this disease are properly resourced including funding for a PrEP programme. “Access to PrEP for those who require is critical and it is essential that this medicine can be accessed in a fair way for those who might not otherwise be able to afford it. The Taoiseach and Minister for Health Simon Harris have both previously committed to a publicly funded PrEP programme by next Summer and we welcome the commitment to achieve this timeline”.

The Bill has faced multiple delays and was filibustered at the final stage by some rural TDs who opposed certain provisions around the drink driving limit. The groundbreaking legislation will mean cancer warnings on alcohol labels and the phasing out of alcohol-related sponsorship of sporting events by 2023. Minister Harris welcomed the passing of the legislation to the Seanad, saying it was “the first time in our history” that Ireland has introduced a public health law for alcohol.

PHARMACIST FINED AFTER UNQUALIFIED WORKER DOLES OUT METHADONE AND PREGABALIN A Northern Ireland pharmacist has been fined £25,000 for allowing an unqualified worker to dole out prescription meds like Methadone and Pregabalin. An inspection audit discovered the crime at Gerard Maginn’s Harts Pharmacy on Main Street, Newcastle, Co Down, last year. Legally, a qualified registered pharmacist must administer potentially dangerous prescription medications. But the 63-year-old had allowed 33-year-old pharmacy technician Gordon Thomson to supply a range of antibiotics, warfarin, Pregabalin and methadone on March 24, 2017. Both men pleaded guilty to the 18 charges against them leading to a first of its kind conviction for Northern Ireland. Maginn was handed 100 hours of community service and a huge fine, while his technician was ordered to do 80 hours community service and pay £1,000 at Downpatrick Crown Court.

PHARMACYNEWSIRELAND.COM | 5


News Pharmacists and GPs call for phasing out of ¤2 medical card prescription levy The Presidents of the Irish Pharmacy Union (IPU), Daragh Connolly, and the National Association of General Practitioners, Dr Maitiú Ó Tuathail, have jointly called on the Government to begin the phasing out of the €2.00 Prescription Levy paid by Medical Card holders, and, at the very least, to exclude vulnerable patients from the levy. Dr Ó Tuathail, a GP at Safetynet Primary Care (a medical charity for marginalised in society) said, “This fee for medications is unjust and is a significant barrier to the accessing of vital medicines for marginalised patients. A system must be introduced whereby marginalised people are exempted from fees which they frequently cannot afford. Eliminating this fee would significantly help these vulnerable patients, and the cost to the exchequer would be negligible.” Referring to a 2016 study funded by the Health Research Board (HRB), and co-authored by researchers in University College Cork and Trinity College Dublin, which revealed that prescription charges on the medical card scheme led to reductions in the use of medicines by Irish patients with some types of medicines being affected more than others, Dr Ó Tuathail said, “Independent research shows that, after the 50 cent prescription charge was introduced in 2010, the use of all medicines reduced, which would have caused a reduction in people’s quality of life and may

even have had an adverse impact on health outcomes such as heart attacks and stroke. We know that the reduction in adherence to many symptom relieving medicines was even greater after the charge was later increased to ¤1.50.” Mr Connolly, a community pharmacist based in Dungarvan, Co Waterford, described the charge as “a levy against health and wellbeing for many people struggling with various ailments and who have very limited financial resources”. The damaging health impact of the levy on many vulnerable patients was highlighted in the findings of a national Behaviour & Attitudes Survey carried out in April, which found that one in six Medical Card holders would “think twice” about taking their prescribed medicines because of the cost of the levy. The Government-imposed levy now stands at ¤2.00 per item, four times higher than when it was first introduced at 50 cent per item in June 2010. Mr Connolly said: “Putting economic barriers in the way of vulnerable patients taking their

IPU President Daragh Connolly medicine doesn’t make sense. People living with heart disease, or at risk of the disease, should be focusing on getting better and keeping well, not worrying about how they will pay for their next vital prescription. Poor adherence to treatments, especially in the case of chronic illness and long-term patients, will mean more hospital stays, more pressure on our already struggling health service, and more costs to the Exchequer in the treatment of these patients in the long run. “Pharmacists and GPs would like to see a phasing-out of the levy and, at the very least, exemptions for especially vulnerable patients, including those in residential care settings; homeless patients; patients receiving treatment under the Methadone Treatment Scheme in respect of other medication that they may require; patients with

intellectual disabilities, and palliative care patients. Patients need to be supported, not penalised,” concluded Mr Connolly. Patients, who, according to the IPU and NAGP, should be exempt from the prescription levy: • People in residential care settings; • People with intellectual disabilities; • Homeless people including those in homeless shelters; • Palliative care patients and others who need to have their medicines changed on a daily/ weekly basis; and • People receiving treatment under the Methadone Treatment Scheme in respect of other medication that they may require.

Ireland’s IP image may be hit by drug patent waiver, pharma body warns Fewer “innovative medicines” will be discovered and made publicly available if the European Union moves to alter patent rights that allow for a drug’s protection period to be extended, a lobby group has said. In a submission to the Department of Business, Enterprise and Innovation, the Irish Pharmaceutical Healthcare Association (IPHA) warned that intellectual property rights for drug manufacturers would be weakened and research facilities placed at risk if the current environment changes. The submission comes as the European Commission proposes to alter the system of patent protection. Currently, medicines are often granted a supplementary protection certificate (SPC), which provides an extension of up to five years to the standard 20-year patent-protection period. Both timeframes, manufacturers argue, compensate them for the time and costs involved in discovery of a new drug.

As part of the single market strategy announced in 2015, the commission proposed to amend the SPC regime, adding an “export manufacturing waiver”. This would result in a shortened patent protection for medicines granted a SPC, allowing copies, or generics, to be produced by manufacturers for export to countries outside the EU. In its submission, the IPHA argued that Ireland would suffer “significant” reputational risk should the waiver be implemented. “By curtailing IP rights, Ireland and Europe are sending a signal to the world that we undervalue our commitment to IP incentives and innovation,” the group said. “Safeguarding a robust IP rights framework in Ireland and Europe

6 | PHARMACYNEWSIRELAND.COM

is crucial to supporting new treatments, jobs and investments spurred by the innovative pharmaceutical industry. “Any putative gains for generics manufacturing in Ireland, a minority part of pharmaceutical manufacturing, should not be considered in isolation from this negative effect on the true source of biopharmaceutical innovation and investment,” it added. The IPHA’s submission noted that foreign-owned pharma companies directly employed 30,000 people in Ireland and had invested close to ¤10 billion in manufacturing and research sites across the country. It flagged recent investment from MSD and Abbott, both which suggested 850 new jobs in their sites would be created over the coming years.

Ireland’s research-based pharma industry, in particular, is under threat, the IPHA said. In 2016, pharma companies invested nearly 33 per cent more in research and development than the software industry, it added. Of the 30,000 pharmaceutical jobs in Ireland, about 4,000 are supported in the generics industry, which believes the SPC waiver could create up to 25,000 new jobs in Europe. “Although it is difficult to quantify the precise impact of the SPC waiver on Ireland’s economy and healthcare territory, we can say with certainty that, without inbuilt safeguards, the change will not incentivise new innovative medicines, new jobs or new investments,” the IPHA concluded.


QuickMist Cool Berry * starts to relieve cravings in 30 seconds Nicorette QuickMist Cool Berry 1 mg/spray, oromucosal spray, solution. Composition: One spray delivers 1 mg nicotine in 0.07 ml solution. 1 ml solution contains 13.6 mg nicotine. Excipient with known effect: Ethanol (less than 100 mg of ethanol/spray). Propylene glycol. Pharmaceutical form: Oromucosal spray, solution. A clear to weakly opalescent, colourless to yellow solution. Indications: For the treatment of tobacco dependence in adults by relief of nicotine withdrawal symptoms, including cravings, during a quit attempt. Permanent cessation of tobacco use is the eventual objective. Nicorette QuickMist Cool Berry should preferably be used in conjunction with a behavioral support program. Dosage: Subjects should stop smoking completely during the course of treatment with Nicorette QuickMist Cool Berry. Adults and Elderly: The following chart lists the recommended usage schedule for the oromucosal spray during full treatment (Step I) and during tapering (Step II and Step III). Up to 4 sprays per hour may be used. Do not exceed 2 sprays per dosing episode and do not exceed 64 sprays (4 sprays per hour, over 16 hours) in any 24-hour period. Step I: Weeks 1-6: Use 1 or 2 sprays when cigarettes normally would have been smoked or if cravings emerge. If after a single spray cravings are not controlled within a few minutes, a second spray should be used. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays. Most smokers will require 1-2 sprays every 30 minutes to 1 hour. Step II: Weeks 7-9: Start reducing the number of sprays per day. By the end of week 9 subjects should be using HALF the average number of sprays per day that was used in Step I. Step III: Weeks 10-12: Continue reducing the number of sprays per day so that subjects are not using more than 4 sprays per day during week 12. When subjects have reduced to 2-4 sprays per day, oromucosal spray use should be discontinued. To help stay smoke free after Step III, subjects may continue to use the oromucosal spray in situations when they are strongly tempted to smoke. One spray may be used in situations where there is an urge to smoke, with a second spray if one spray does not help within a few minutes. No more than four sprays per day should be used during this period. Regular use of the oromucosal spray beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the oromucosal spray longer to avoid returning to smoking. Any remaining oromucosal spray should be retained to be used in the event of sudden cravings. Paediatric population: Do not administer this medicine to persons under 18 years of age. There is no experience of treating adolescents under the age of 18 with this medicine. Method of administration: After priming, point the spray nozzle as close to the open mouth as possible. Press firmly the top of the dispenser and release one spray into the mouth, avoiding the lips. Subjects should not inhale while spraying to avoid getting spray into the respiratory tract. For best results, do not swallow for a few seconds after spraying. Subjects should not eat or drink when administering the oromucosal spray. Behavioural therapy advice and support will normally improve the success rate. Contraindications: Hypersensitivity to nicotine or to any of the excipients. Children under the age of 18 years. Those who have never smoked. Special warnings and precautions for use:

* based on 2 x 1mg dose

This medicine should not be used by non-smokers. The benefits of quitting smoking outweigh any risks associated with correctly administered nicotine replacement therapy (NRT). A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: Cardiovascular disease: Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, recent cerebrovascular accident and/or who suffer with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, the oromucosal spray may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision. Diabetes Mellitus. Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when smoking is stopped and NRT is initiated as reduction in nicotine induced catecholamine release can affect carbohydr carbohydrate metabolism. Allergic reactions: Susceptibility to angioedema and urticaria. Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects. Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines. Gastrointestinal Disease: Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and NRT preparations should be used with caution in these conditions. Paediatric population: Danger in children: Doses of nicotine tolerated by smokers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be handled or ingested by children. Transferred dependence: Transferred dependence can occur but is both less harmful and easier to break than smoking dependence. Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, tacrine, clozapine and ropinirole. The plasma concentration of other medicinal products metabolised in part by CYP1A2 e.g. imipramine, olanzapine, clomipramine and fluvoxamine may also increase on cessation of smoking, although data to support this are lacking and the possible clinical significance of this effect for these drugs is unknown. Limited data indicate that the metabolism of flecainide and pentazocine may also be induced by smoking. Excipients: The oromucosal spray contains small amounts of ethanol (alcohol), less than 100 mg per spray. Limited data indicate that the metabolism of flecainide and pentazocine may also be induced by smoking smoking. Excipients: The oromucosal spray contains small amounts of ethanol (alcohol), less than 100 mg per spray. It also contains propylene glycol which may cause skin irritation. Care should be taken not to spray the eyes whilst administering the oromucosal spray.

Undesirable effects: Effects of smoking cessation: Regardless of the means used, a variety of symptoms are known to be associated with quitting habitual tobacco use. These include emotional or cognitive effects such as dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, and restlessness or impatience. There may also be physical effects such as decreased heart rate; increased appetite or weight gain, dizziness or presyncopal symptoms, cough, constipation, gingival bleeding or apthous ulceration, or nasopharyngitis. In addition, and of clinical significance, nicotine cravings may result in profound urges to smoke. This medicine may cause adverse reactions similar to those associated with nicotine given by other means and these are mainly dose-dependent. Allergic reactions such as angioedema, urticaria or anaphylaxis may occur in susceptible individuals. Local adverse effects of administration are similar to those seen with other orally delivered forms. During the first few days of treatment irritation in the mouth and throat may be experienced, and hiccups are particularly common. Tolerance is normal with continued use. Daily collection of data from trial subjects demonstrated that very commonly occurring adverse events were reported with onset in the first 2-3 weeks of use of the oromucosal spray, and declined thereafter. Adverse reactions with oromucosal nicotine formulations identified from clinical trials and during post-marketing experience are presented below. The frequency category has been estimated from clinical trials for the adverse reactions identified during post-marketing experience. Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); not known (cannot be estimated from the available data). Immune system disorders Common Hypersensitivity Not known Allergic reactions including angioedema and anaphylaxis Psychiatric disorders Uncommon Abnormal dream Nervous system disorders Very common Headache Common Dysgeusia, paraesthesia Eye disorders Not known Blurred vision, lacrimation increased Cardiac disorders Uncommon Palpitations, tachycardia Not known Atrial fibrillation Vascular disorders Uncommon Flushing, hypertension Respiratory, thoracic and mediastinal disorders Very common Hiccups, throat irritation Uncommon Bronchospasm, rhinorrea, dysphonia, dyspnoea, nasal congestion, oropharyngeal pain, sneezing, throat tightness Gastrointestinal disorders Very common Nausea Common Abdominal pain, dry mouth, diarrhoea, dyspepsia, flatulence, salivary hypersecretion, stomatitis, vomiting Uncommon Eructation, gingival bleeding, glossitis, oral mucosal blistering and exfoliation, paraesthesia oral Rare Dysphagia, hypoaesthesia oral, retching Not known Dry throat, gastrointestinal discomfort, lip pain Skin and subcutaneous tissue disorders Uncommon Hyperhidrosis, pruritus, rash, urticaria Not known Erythema General disorders and administration site conditions Common Burning sensation, fatigue Uncommon Asthenia, chest discomfort and pain, malaise malaise. MAH: Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland. PA Number: PA 330/37/16. Date of revision of text: May 2018. Product not subject to medical prescription. Full prescribing information available upon request.


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Republic of Ireland: www.aptamilhcp.ie Northern Ireland: www.eln.nutricia.co.uk References: 1. Verwimp JJ et al. Eur J Clin Nutr. 1995;49 (Suppl1):S39-S48. 2. Giampietro PG et al. Pediatr Allergy Immunol. 2001;12:83-86. 3. Arslanoglu S et al. J Biol Regul Homeost Agents. 2012;26:49-59. 4. O’ Carroll, E, Redmond, M et al. (2018), A blinded palatability study comparing two extensively hydrolysed infant formula used for the dietary management of Cows’ Milk Allergy in Ireland. The Nutrition Society Advancing Nutritional Science Spring Conference OC18.

IMPORTANT NOTICE: Aptamil Pepti 1 & 2 are foods for special medical purposes for the dietary management of cows’ milk allergy. They should only be used under medical supervision, after full consideration of the feeding options available including breastfeeding. Aptamil Pepti 1 is suitable for use as the sole source of nutrition for infants from birth, and/or as part of a balanced diet from 6-12 months. Aptamil Pepti 2 is suitable for babies over 6 months as part of a mixed diet.

FOR HEALTHCARE PROFESSIONAL USE ONLY.

17-026 / March 2018


Profile

Team effort keeps independent pharmacy moving from strength to strength Located in a suburb of West Dublin, Roselawn Sheridan’s Pharmacy is a five-year-old independent store that is punching above its weight. Des Sheridan is the proprietor and Superintendent Pharmacist. “When I started the business the idea I had for it was to provide a personal style pharmacy service to customers. Whilst our competitors here in the shopping centre have a fantastic product range, we identified a definite gap in the market for a more independent pharmacy and things have been going really well for us. “People nowadays are much more focused on their health and well-being and are looking for products that promote prevention rather than cure, and I would have always been keen to expand our offering in terms of vitamins and health food products. We introduced a range in the pharmacy and when we saw how popular that was with our customers we expanded on it, and when this unit became available I was in a position to be able to acquire it and open the health food store just a few doors down from the pharmacy. It has been a very successful expansion.” Community Pharmacy Originally from Ballyjamesduff in Cavan, Sheridan tells Irish Pharmacy News that there is a great community spirit in Roselawn. “We run a charity event every year and the people around here are very generous and are happy to give when they are informed about the particular charity you are fundraising for. It is an opportunity for us to give back, while also maintaining our visibility in the community. I have a fantastic team here and over the years we have developed a really good mix and we go on team building days and often socialise together. None of this would be possible without the team. I like to bring people on board who have something special to offer.” Jessica Melia is the manager in Sheridan’s Pharmacy. “Des saw potential in me in the

beginning and when he gave me the opportunity to manage the store I had some suggestions on how I felt things could be improved. I went into the local competitor store as a mystery shopper and I asked for an OTC product to see what their customer engagement was like: were they link selling? Were they upselling? Were they giving additional advice? I discovered that if we concentrated on providing this type of service to our customers that it would bring us opportunities and because we were trending at a certain amount every month I knew we could perform better. “We educated the staff on the front counter and also ran incentive schemes to encourage them to use the information they had learned so that they could give the customers that little bit extra. I suggested turning the orientation of the shop floor around and Des had faith in me and implemented this initiative. “Every department was missing top sellers, so instead of carrying a huge range of plasters, we now just have two of the top brands, which gave us more room to stock, for example, two different types of antiseptic, rather than having no antiseptic at all. We are right beside a dentist, an opticians and a doctor’s surgery, so we approached them and asked which specialist OTC products they would be likely to recommend to their patients and we endeavour to always have these in stock. We also merchandised according to the planograms and have seen significant growth, not just year on year, but also month to month.” Melia also knows that community pharmacy is about more than the bottom line. “People come into the pharmacy to get advice and to find products that will make them feel better. We want our community to know that we care about whatever the problem

Pharmacist and proprietor Des Sheridan with pharmacy manager Jessica Melia, outside the health food store

is. You need a certain amount of humanity, a certain amount of feeling, understanding and empathy to be in this type of work and the OTC staff are the frontline so it is important to be able to read the customers' needs and to help them as much as we can. “This is what has actually contributed most to the growth of this business: people around here know now that we are qualified, highly trained and that we are eager to help, no matter what their query is, from mental health, to skincare and cosmetics customers know that they can come to us for anything. We cater to that and listen to their needs. Des is really passionate about this aspect

of the service and is always open to hearing new ideas and trying new things to benefit the business and the customers.” Dispensary Challenges Chris Connolly is the Supervising Pharmacist in Sheridan’s. “I’d locumed here for a few days and even though I wasn’t exactly looking for full time work, when the position came up and Des offered it to me I took it because I liked the staff and I liked the shop. There are three full time pharmacists now in the store so between us we have it mostly covered.” Connolly and the other regular pharmacists, Des Sheridan and Mathew Campbell, look

PHARMACYNEWSIRELAND.COM | 9


Profile High Standard Mathew Campbell has been a qualified pharmacist for two years. “It has been a big change and I have learned a lot. I did a year in the North working for a group and now working here I have found that there is a lot more responsibility and you have more opportunities to change things around instead of just accuracy checking. I like working in community because you get to chat to people and that speeds your day up. Des is a great employer, he sets a high standard and is not afraid to invest in his staff. The OTC staff regularly go on courses and that makes our job easier because if they are able to talk to customers about, for example, iron deficiency, it frees us up and allows us to look after our responsibilities in the dispensary.”

Team members Mary McKay, Jessica Melia, Karen Marten with pharmacists Chris Connolly and Matthew Campbell

after the dispensary ordering and Campbell tells IPN about the benefits, and drawbacks, associated with being part of a buying group. “We don’t have a lot of space here so from our point of view it is useful to be able to buy things in ones and twos, rather than having to buy in bulk, because you still receive the same discount. The only trouble with that is, there are a number of different generics companies and the buying group could change who they purchase stock from on a weekly basis. The different brands can therefore

change and this sometimes causes issues when you are supplying medication to the patient because when it comes to their medication, many people don’t like change. “It is hard enough getting them to switch from a brand to a generic, but then when the generic keeps changing, they might think it is another new medication so this is a challenge we have to try to overcome by giving patients reassurance. The buying group will always send you the cheapest product but if you choose something that is more expensive it can be difficult

to work out how much you are being charged, and you often won’t know that until you get your invoice. “That is why it is sometimes easier to stick with what they send. By and large though, people are coming around to the idea that the generic is equally effective so once you take the time to explain to them that nothing has changed they are usually very happy to follow your recommendation. There is always something to brush up on and keep up to speed with in pharmacy and I enjoy the challenge.”

Manager Jessica Melia tells IPN that identifying opportunities and building on them is what has brought so much success to the company. “We were in a position that there was room for growth and now for everyone to be able to witness the expansion and the constant evolution, it really gives the whole team a sense of pride that due to their hard work and customer service, Des was able to open a second unit. We have all worked so well together and it wasn’t just down to one person. I am very proud of what we have all been able to achieve together and this is what I love about my job: being there to see first-hand the fruit of your efforts. That it what makes it all worth it.”

News MSD announces new manufacturing facility and 170 new jobs for Carlow MSD, known as Merck in the U.S. and Canada, has announced that it will construct a second manufacturing facility at its existing site in Carlow with the creation of 170 new jobs. The new facility will focus on the production of vaccines and biologics and is scheduled to commence manufacturing operations in 2023. The build will include an expansion of warehouse and laboratory services at the site. Recruitment for the new facility will commence immediately. MSD is one of Ireland’s leading healthcare companies and currently employs approximately 2,000 employees across its current operations in Carlow, Cork, Dublin and Tipperary. Currently employing over 400 staff, MSD Carlow opened in 2008 as MSD’s

first vaccines facility outside of the US. The expansion is as a result of continuing increased global demand for MSD’s medicines and vaccines. MSD continues to invest significantly in R&D to invent new vaccines and medicines for areas of unmet need. Earlier in 2018 MSD also announced it had decided to locate a new facility, MSD Biotech, Dublin, in Swords, Co. Dublin with the expected creation of up to 350 jobs when that facility commences full manufacturing operations in 2021.

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Ger Brennan, Managing Director of MSD Human Health in Ireland, said: “We are delighted to be able to announce this further expansion of MSD’s footprint in Ireland which comes on the back of a number of significant investments in our facilities across Ireland in 2017 and the announcement earlier this year that a new facility would be built in Dublin. MSD’s continued investment in Ireland is due to continued access to highly-skilled employees as well as collaborative partnerships with Government and Third Level institutions.” Karin Shanahan, SVP, Global

Biologics & Sterile Ops, MSD, said that, “The decision to further invest in Carlow is a real testament to the talent of the current Carlow team and MSD Ireland’s wider employee base and reinforces MSD’s commitment to Ireland, further strengthening our 50year strong legacy here. Today’s announcement only adds to our ability to be able to offer current and future employees a truly unique experience across our sites in Ireland, offering an opportunity to experience all elements of pharmaceutical and biotech manufacturing within Ireland.”


The only COPD Triple Therapy delivered in a single daily inhalation.1 Improvement in lung function and quality of life vs. ICS/LABA. 2,3

NE W A combination of ICS/LAMA/LABA (FF/UMEC/VI)) m administered through a single daily inhalation from the Ellipta inhaler, which is easy to use1–5

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. TRELEGY Ellipta FF/UMEC/VI 92/55/22 mcg OD is indicated for maintenance treatment in adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an ICS and a LABA.1 COPD, chronic obstructive pulmonary disease; FF, fluticasone furoate; ICS, inhaled corticosteroids; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OD, once-daily; UMEC, umeclidinium, VI, vilanterol. References: 1. Trelegy Ellipta 92/55/22 mcg SPC. 2. Lipson DA et al. Am J Respir Crit Care Med 2017; 196:438–446. 3. Lipson DA, et al. N Engl J Med. May 3 2018;378(18):1671-1680 4. Svedsater H et al. BMC Pulm Med 2013; 13:72–86. 5. van der Palen J et al. NPJ Prim Care Respir Med 2016; 26:16079. Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol [as trifenatate]) Prescribing information. Please consult the full Summary of Product Characteristics (SmPC) before prescribing. Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol [as trifenatate]) inhalation powder. Each single inhalation of fluticasone furoate (FF) 100 micrograms (mcg), umeclidinium bromide (UMEC) 62.5 micrograms and vilanterol as trifenatate (VI) 25 mcg provides a delivered dose of 92 mcg FF, 55 mcg UMEC and 22 mcg VI. Indications: Maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA). Dosage and administration: One inhalation once daily at the same time each day. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate & magnesium stearate). Precautions: Paradoxical bronchospasm, unstable or life-threatening cardiovascular disease or heart rhythm abnormalities, convulsive disorders or thyrotoxicosis, pulmonary tuberculosis or patients with chronic or untreated infections, narrow-angle glaucoma, urinary retention, hypokalaemia, patients predisposed to low levels of serum potassium, diabetes mellitus. In patients with moderate to severe hepatic impairment patients should be monitored for systemic corticosteroid-related adverse reactions. Eye symptoms such as blurred vision may be due to underlying serious conditions such as cataract, glaucoma or central

A full list of adverse reactions can be found in the Summary of Product Characteristics. In common with other corticosteroid-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with TRELEGY Ellipta.1 Trelegy Ellipta should be used with caution in patients with unstable life-threatening cardiovascular disease.1

Please see www.trelegy.ie to find out more

serous chorioretinopathy (CSCR); consider referral to ophthalmologist. Increased incidence of pneumonia has been observed in patients with COPD receiving inhaled corticosteroids. Risk factors for pneumonia include: current smokers, old age, patients with a history of prior pneumonia, patients with a low body mass index and severe COPD. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Trelegy. Acute symptoms: Not for acute symptoms, use short-acting inhaled bronchodilator. Warn patients to seek medical advice if short-acting inhaled bronchodilator use increases. Therapy should not be abruptly stopped without physician supervision due to risk of symptom recurrence. Systemic effects: Systemic effects of ICSs may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids. Interactions with other medicinal products: Caution should be exercised with concurrent use of β-blockers. Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products), hypokalaemic treatments or non-potassium-sparing diuretics. Co-administration with other long-acting muscarinic antagonists or long acting β2-adrenergic agonists is not recommended. Pregnancy and breast-feeding: Experience limited. Balance risks against benefits. Side effects: Common (≥1/100 to <1/10): pneumonia, upper respiratory tract infection, pharyngitis, rhinitis, influenza, nasopharyngitis, headache, cough, arthralgia, back pain. Uncommon (≥1/1,000 to <1/100): candidiasis of mouth and throat, viral respiratory tract infection, supraventricular tachyarrhythmia, tachycardia, atrial fibrillation, oropharyngeal pain, fractures; Not known (cannot be estimated from the available data): vision blurred. Marketing Authorisation (MA) Holder: GlaxoSmithKline Trading Services Limited, Curabinny, Co. Cork, Ireland. MA No. [EU/1/17/1236/002]. Legal category: POM B. Last date of revision: June 2018. Job Ref: IE/TLY/0006/17(1). Further information available on request from GlaxoSmithKline, 12 Riverwalk, Citywest Business Campus, Dublin 24. Tel: 01-4955000.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling: (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255. TRELEGY Ellipta was developed in collaboration with TRELEGY and Ellipta are registered trademarks of the GlaxoSmithKline Group of Companies. © 2018 GlaxoSmithKline Group of Companies. All rights reserved. Zinc code: I E /TLY/0004/17(2) Date of preparation: July 2018


News Majority of pharmacists disagree with PSI rule change Results of an online survey indicate that the majority of chemists disagree with new proposals relating to the temporary absence of a pharmacist.

Conor Phelan, Director of Phelan's Pharmacy

Last month IPN revealed that The Pharmaceutical Society of Ireland (PSI) is set to introduce rules under section 30 of the 2007 Pharmacy Act that will change the work practices of pharmaceutical assistants, and will limit their ability to cover for absent pharmacists. Pharmabuddy.ie, which is an online resource used to improve communication in the sector, carried out an online poll asking the question ‘Do you agree with PSI Council’s decision to redefine temporary absence rules?’

Of those who responded 19 people (8.15%) said Yes, 209 (89.7%) said No and five (2.15%) responded Maybe.

regrettable decision and the workers should be allowed to fulfill the natural expectations they had when they qualified.

Irish Pharmacy News spoke to several employer pharmacists to measure their support for the proposed changes.

“The implementation of the Pharmacy Act 2007, which by and large has been executed by people who are removed from community pharmacy, has caused a lot of friction and what irritates pharmacists is the unwillingness to utilise the experience we have.”

Conor Phelan, director of the family-owned group Phelan’s Pharmacy, said: “I think it is regrettable that this has come to pass and it would have been more preferable had the pharmaceutical assistants been brought under the umbrella of the PSI and been made subject to CPD requirements, and allowed to continue to practice in the way they have for decades. I do not think the PSI has given serious consideration to alternatives, such as updating the legislation to bring pharmaceutical assistants under its remit. “They should be treated in the same way as pharmacists and should be subject to sanction from the PSI rather than suddenly having the rug suddenly pulled from under them. The issue needed to be addressed, in that the PSI should certainly have the power to sanction qualified assistants, but I do not believe it was addressed in the right way. If they can cover an absent pharmacist for an hour, what is wrong with allowing them to cover for two hours?” Richard Collis also spoke to Irish Pharmacy News about the proposed changes. “It is a very

One employer pharmacist, speaking anonymously, added: “The PSI needed to do something about regulation and standards regarding CPD, and could have decided to facilitate these workers because there is a crisis in getting locums at the moment, particularly in rural Ireland. “These women's livelihood, and they are mostly women, is being undermined and there is a potential they could take a High Court action. It is in the Constitution: you have a right to protection of your livelihood, and it cannot be unilaterally withdrawn from you, but in this case it will be withdrawn from these workers. “It probably will lead to the closure of pharmacies on Saturdays and [the rates] are like a bidding war. You would be better off just to close the shop than to pay a hundred euros an hour to a locum.” In a statement the PSI said: “Until such time as the draft PSI (Temporary Absence of a

Pharmacist from a Pharmacy) Rules 2018 are considered and consented to by the Minister, the proposed Rules are not enacted and no change in practice is occurring. “On Thursday, 20 September, the PSI Council considered draft Rules (named above) following their consideration and attention to this matter over recent years. The Pharmacy Act 2007 creates a framework whereby patients and members of the public can expect that a pharmacist will be available and practising within a pharmacy when they attend for medicines or to obtain advice on a health or medicines matter. “The matter of the temporary absence of a pharmacist from a pharmacy is provided for in Section 30 of the Act, and the Council may make Rules in this regard. In doing so, the Council considered feedback to the public consultation that had been undertaken in relation to the draft Rules during July and August, and other material. You will find related information on that consultation, as well as a previous consultation in 2016, on our website. As with all public consultations, overview of the submissions received during this recent public consultation process will shortly be made available on this webpage also. You will also note that the Working Group report, which provided the Council with its policy basis for proceeding with the Rules, is also available on that page.”

Social and cultural factors contributing to the rise of type 2 diabetes New research suggests that initiatives designed to address the alarming rise in the incidence of type 2 diabetes will be ineffective if not accompanied by strategies that take account of factors such as food traditions and gender roles. The alarming rise in the rates of type 2 diabetes is fueled mainly by increasing obesity rates and diabetes could affect one in nine adults by 2045 – more than 730 million. The findings from the Cities Changing Diabetes research were presented at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD 2018) in Berlin, Germany. David Napier, who is professor of Medical Anthropology at University College London (UCL), told delegates: "For many years, diabetes has continued to rise at an alarming rate despite the best efforts of policymaker and healthcare providers … In order to turn the table on this devastating

and costly disease, we need to think differently and adopt new approaches. When public health strategies and individual care plans take into account the prevailing local cultures and associated conventions and behaviours, they are much more likely to be successful." Researchers pointed to a number of social and cultural factors that they believe is contributing to the rise of diabetes in cities around the world, including: standard medical referral practices acting as barriers to preventive care and services

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for diabetes (Copenhagen); food traditions becoming entwined with heritage and culture and often being perceived as providing ‘comfort’ (Houston): traditional gender roles limiting effective selfcare in male-only households, as some men are unable or unwilling to provide diabetes support to others (Mexico City). Research also demonstrated that rates of diabetes and obesity are accelerating in every region of the world today, not just in North America and Europe, where obesity has been rising

for decades. Africa, on the other hand, is projected to see a nearthreefold increase in the number of people living with diabetes as the population ages and obesity prevalence increases. "Whether it's by initiating doorto-door care provision, relocating clinics within urban communities or through enabling peer support among religious faith groups, the many partners are already acting to great effect on these findings," said Niels Lund, vice president for Health Advocacy, Novo Nordisk.


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Feature Pharmacists helping parents in the community: reflux, intolerance and milk allergies New parents will make numerous trips in the first few weeks and months of their infant’s life, seeking advice and reassurance from a trusted source. Community pharmacists are in the unique position of being not only one of the most accessible health care providers, but also one of the most dependable. Flexible opening times mean members of the public, including new parents, can access professional medical advice up to seven days a week. also accompanied by respiratory issues, such as a wheeze or runny/congested nose, or skin reactions such as a rash, hives or unresponsive eczema, the patient should be referred to the GP for investigation of possible cow’s milk protein allergy (CMPA). If a diagnosis of CMPA is made by a doctor, parents of these children can then be supported in the pharmacy in line with their medical and dietary advice.

Feeding problems can be stressful for both parents and baby

Irish Pharmacy News spoke to Jane Fitzsimons, who is a Supervising Pharmacist with LloydsPharmacy in Dublin’s Aylesbury, about the recently updated guidelines issued by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Fitzsimons shares her tips for pharmacists on advising parents who are caring for a baby who presents with gastrointestinal issues. “Whether this is their first, second, or even third baby, parents will always have questions. A big aspect of my role is to make parents comfortable as they will often come into the pharmacy just to make sure they are on the right track. Feeding problems are stressful for both the parent and the infant so a pharmacist should be ready to listen and offer solutions. When these issues come up it is important to reassure parents that they will get the help they need from their pharmacist.” Regardless of whether a baby is breast- or bottle-fed, many

infants develop symptoms associated with gastrointestinal reflux disorder and Fitzsimons tells IPN that you have to work with parents in stages to see which products will help. “As a pharmacist, you have to do some probing to discover if this is something that can be treated by you or if the patient needs to be referred on. Sometimes a reflux issue can be resolved by simply offering parents feeding advice, such as giving smaller volumes of milk more regularly. Elevating the head of the crib or Moses basket and waiting for 30 minutes to lay the child down after feeding will help to alleviate some of the milder symptoms of regurgitation, which in small amounts is normal in babies. Help the parents to figure out what is working and what is not by discovering which methods bring the best results, using a step-by-step process. “It is often a case of trial and error. We advise parents to be mindful of their technique and to try to reduce the amount of air that the baby is taking

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in during feeds, whether from the breast or bottle. Reassure parents that it is perfectly fine to interrupt feeding to burp a baby who suffers badly with wind as eliminating excess air may help to alleviate discomfort and pain. If bottle-feeding, the teat size is also very important as an incorrect teat size may result in baby taking in excess air during feeding. There are different types of feeding bottles available that come with patented anti-reflux and anti-colic mechanisms which are known to have benefits by diverting air away from the teat to the bottom of the bottle using special valve. These types of feeding bottles do work and parents have reported to me that their child’s symptoms have improved when these types of feeding products were introduced.” Fitzsimons also says that although many cases can be managed in the pharmacy, it is time to refer on to the GP if symptoms are more severe (such as projectile vomiting or persistent diarrhoea). Similarly, if

“From a pharmacist’s point of view, working with the parents on a step-by-step basis, we are here and ready to signpost parents on the right course of action when faced with sometimes complex gastrointestinal issues. From a parent’s point of view, it is very reassuring to know that the right care, supports and products are available when required to help improve the baby’s health and well-being, and maybe even help everyone get a good night’s rest.”

Sometimes a reflux issue can be resolved by simply offering parents feeding advice


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News Spot the difference between cold and flu Boots Ireland is launching a new campaign to raise awareness and understanding of the difference between the cold and the flu. The following provides information on how to tell the difference between a cold and the flu

Dr Cillian De Gascun, consultant virologist and laboratory director at the UCD National Virus Reference Laboratory Compared to the common cold the flu is a far more serious viral infection and results in a number of deaths and hospitalisations in Ireland each year. The main symptom difference between a cold and flu is that the symptoms of influenza come on rapidly and are accompanied by muscle aches and a high fever. Other symptoms of flu include: headache, extreme exhaustion, coupled with fatigue and weakness which can last up to three weeks. A cold usually starts gradually with a sore throat and a blocked or a runny nose. Symptoms of a cold are generally mild compared to the flu. There are over 200 forms

Symptoms

Seasonal flu

Cold

Fever

High fever lasts 3-4 days

Rare

Headache

Prominent

Rare

General Aches, Pains

Usual; often severe

Slight

Fatigue, Weakness

Can last up to 2-3 weeks

Quite mild

Extreme Exhaustion

Early and prominent

Never

Stuffy Nose

Sometimes

Common

Sneezing

Sometimes

Usual

Sore Throat

Sometimes

Common

Chest Discomfort, Cough

Common; can become severe

Mild to moderate; hacking cough

of cold virus and most adults have two to four colds a year; children can get six to 10.

when it’s not needed can cause some unnecessary side effects without providing any benefit.

Speaking about this year’s influenza activity, Dr Cillian De Gascun, consultant virologist and laboratory director at the UCD National Virus Reference Laboratory said: “At present, we are seeing very little influenza activity in Ireland, so it’s a good time to get the vaccine, as it takes about two weeks to take effect. Getting the flu vaccination is the best preventive measure we have against influenza, especially for people in the at-risk groups.”

However, getting a flu vaccination reduces the risk of getting the flu by up to 60%. People over the age of 65 years, pregnant women and those with long term health conditions are in an “at risk group” and strongly recommended to get the flu vaccination at this time of year, as they have a greater chance of developing complications from flu.

Antibiotics do not work on either a cold or flu and taking an antibiotic

Susan O’Dwyer, Pharmacist, Boots Ireland said: “There are lots of easy steps you can take to ensure you feel well this winter. One of the best is to ensure you

are vaccinated against the flu virus. Vaccination is strongly recommended for those over 65, people with long-term health conditions, carers and pregnant women as it’s the best way to help prevent getting and spreading the flu. At Boots we provide a vaccination service in all 84 of our pharmacies nationwide. With most of our pharmacies open late at night and seven days a week you are sure to find a convenient time to receive your vaccination. If you have any questions about winter wellness or Boots vaccination services, talk to one of our in-store pharmacists.”

Flu vaccine now available in pharmacies nationwide The 2018/9 Seasonal Flu Vaccine is now available in pharmacies nationwide. After a particularly severe flu season in 2017/8 pharmacists are advising that getting the flu vaccine early this year, is the key to avoiding infection. All those in at-risk groups who hold a medical card can get the vaccine free of charge at their local pharmacy. Speaking as the Irish Pharmacy Union (IPU) launched its annual campaign encouraging people to get a flu vaccine, IPU President Daragh Connolly explained “Influenza (the flu) is a highly infectious and potentially serious disease. In the Northern Hemisphere the flu season typically lasts from October to April. In 2017 Ireland experienced a particularly severe flu season which led to the hospitalisation of 4,680 people and tragically the death of over 200*. “The annual seasonal flu vaccine has been shown to be the best protection against flu. The most effective time to get the flu vaccine

is before flu begins spreading in your community. After vaccination it takes about two weeks for the antibodies to develop and for your protection to be maximised. Therefore, early vaccination is highly recommended, particularly for those in at risk groups.”

vaccinations. Since pharmacists first started vaccinating in 2011, flu vaccine deliveries have increased overall by 29%. This shows that when pharmacists vaccinate, public awareness increases, and vaccination rates increase through all channels.”

Data collated by the Irish Pharmacy Union (IPU) has shown that since the flu vaccine has been made available in pharmacies there has been a significant nationwide increase in uptake of the vaccine. According to Mr Connolly, “last year pharmacists provided 115,000 vaccines to patients nationwide, representing 13% of all flu

Mr Connolly added that “Pharmacists in other countries can routinely offer a wider vaccination service and this is something that should be allowed in Ireland. This should include vaccination against meningococcal disease, tetanus and hepatitis A and B, as well as travel vaccines.”

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Mr Connolly concluded by saying,

“With nearly 78 million visits to community pharmacies every year, pharmacists are the most accessed healthcare professional in Ireland. The work undertaken by pharmacists delivers significant benefits to both patients and the State by taking pressure off other parts of the healthcare system, including GPs and hospitals, allowing them to focus on patients with more complex conditions who require greater medical intervention. We believe that allowing pharmacists to practise to full scope will deliver better patient outcomes and are committed to working with Government to implement this.”


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News Concerns over dispensing of anticonvulsant medication

news brief FINDINGS OF STRESS AND WELLBEING SURVEY OF PHARMACISTS REVEALED Pharmacists’ Support Service (PSS) executive officer Kay Dunkley presented a paper at the International Practitioner Health Summit 2018: The Wounded Healer in London. After presenting the findings of the National Stress and Wellbeing Survey of Pharmacists, Intern Pharmacists and Pharmacy Students to an international audience, Ms Dunkley attended the Pharmacy Show in Birmingham and met with the UK Pharmacist Support staff in their Manchester offices. During her time at the Wounded Healer Summit, Ms Dunkley said she learned about initiatives across a wide range of health professions including medical, dental, nursing, pharmacy, veterinary and allied health professionals. “Themes of the conference included resilience and healthy workplaces; mindfulness; the emotional impact of caring; burnout among health professionals; mistakes, complaints and blame culture; mental health management and stigma in health professionals; addiction in the health professional; impairment and management by regulators; and suicide in health professionals,” she said.

TOP 100 OTC PRODUCTS: VOLTAROL In the August 2018 edition of IPN we published a Top 100 list of OTC products. Due to a production error the list was not compiled with the same methodology as in previous years and this led to Voltaral being given a position which was not a fair comparison. We apologise for the error and have re-printed the full list in this edition to represent the true positions.  See page 70/71

The Pharmaceutical Society of Ireland (PSI) has been contacted in recent months about nine supplies of valproate medicines indicated to have been made without the required alerts, educational material or counselling by pharmacists. Rather than receiving the drug according to the European-wide Pharmacovigilance Risk Assessment Committee (PRAC) recommendations, it was supplied to some patients in small plastic bags without an accompanying Patient Information Leaflet (PIL) and Valproate Card. A spokesperson for the PSI confirmed that action had been taken at pharmacy level following receipt of concerns by the regulator. Karen Keely is the chairperson for the Organisation for AntiConvulsant Syndrome (OACS Ireland) and has three boys who are affected by foetal anticonvulsant syndromes (FACS). Keely shared with Irish Pharmacy News that OACS has evidence that some pharmacists in Ireland are continuing to supply Epilim to patients inappropriately, as recently as September this year, in addition to the nine cases that the PSI is aware of. Representatives of FACS Forum Ireland intend to meet seek a meeting with pharmacy

regulator to share evidence of these cases. Foetal exposure to sodium valproate causes developmental disability in 30-40% of babies born to mothers who are using the drug, and carries a 10% risk of birth defects. It is not yet known why FACS affects some children and not others, but it is believed that there could be a genetic link that creates an enhanced risk. Listed by the World Health Organisation (WHO) as an essential medicine, valproate is indicated in the treatment of migraine, bipolar disorder, and epilepsy, among other conditions. Sanofi manufacture a commonly used brand, Epilim. The European Medicines Agency (EMA) strengthened warnings on valproate-based medicines in 2014 and another review in 2017 found that warnings were still not effective enough. Dr Jim Morrow is the founder of the UK Epilepsy and Pregnancy Register and member of Epilepsy

Action’s Women’s Advisory Panel. “We know sodium valproate is an effective, easy-to-use and generally well-tolerated drug for women with epilepsy. Unfortunately, this means non-neurology specialists are more likely to prescribe it, which can mean women can take the drug without being fully aware of the risks involved or having regular reviews.” Separately, the Department of Health confirmed that the State Claims Agency has received notice of proceedings from solicitors in Ireland representing people who are allegedly living with the effects of foetal anticonvulsant syndrome. Valproate, and its valproic acid, sodium valproate, and valproate semisodium forms, are medications primarily used to treat epilepsy and bipolar disorder and to prevent migraine headaches. They are useful for the prevention of seizures in those with absence seizures, partial seizures, and generalised seizures.

Fifty years in the business - 100 years in the making Leitrim pharmacy, Kieran's totalhealth is celebrating half a century of service. Brendan Kieran's grandfather opened his pharmacy 100 years ago in Ballinamore, County Leitrim and his parents opened a store in Carrick-on-Shannon in 1968. "We all moved into the property, so I grew up in this business, literally!' Kieran has been running the business since 2000 and moved to a bigger premises in 2001. A second branch opened in Mohill in 2004. Marking their remarkable achievement of 50 years in business, Kieran and his team recently organised the latest in a year-long series of celebrations: a Ladies' VIP night in Carrick-on-Shannon. Kicking off with a reception in a local café, attendees were treated to make-overs, product demos, expert advice, and goodie bags. Neighbours BR Cafe and cake company Bits and Bytes supplied the locally made refreshments. Fifty years of service has been more than eventful for this pharmacy family. The original Carrick-on-Shannon branch was completely refurbished in 2011 and the Mohill store received a total makeover in 2014. Kieran says one decision in particular was transformative to the business.

18 | PHARMACYNEWSIRELAND.COM

Brendan Kieran SNR, MPSI and wife Margaret Kieran, with their son, Brendan Kieran MPSI, owner Kieran's totalhealth, and his wife, Shauna Kieran "The biggest and best change was our joining the totalhealth group", he says. "Our customers have embraced the brand as much as our team has, enjoying the new products and promotions we can now offer them. The support has been immense and has made the business a success. This is something I couldn't have achieved as an independent pharmacy owner in Ireland."

Though the pharmacy that started it all in Ballinamore closed its doors in 2005, Kieran does not plan on taking his foot off the pedal anytime soon. "We look forward to the future and to serving our communities for the next 50 years, and beyond." Totalhealth, which is a symbol group owned 100 percent by its members, represent over 70 pharmacies nationwide.


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Contraindications: Hypersensitivity to any of the ingredients, hyperthyroidism, diabetes, cardiovascular disorders, patients who are taking or have taken monoamine oxidase inhibitors within the last two weeks, those taking tricyclic anti-depressants or patients currently receiving other sympathomimetics, phaeochromocytoma, prostatic enlargement or urinary retention, glaucoma, hepatic and renal impairment and porphyria. Precautions: Circulatory disorders, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. May be harmful to people with phenylketonuria. May act as cerebral stimulant. Do not take with alcohol. Pregnancy and lactation: Not to be taken during pregnancy or whilst breast feeding. Side effects (unknown frequency): Agranulocytosis, thrombocytopenia, abnormal hepatic function, anaphylaxis, cutaneous hypersensitivity reactions, bronchospasm. See SmPC for full list of side effects and further information. Legal classification: P. PA 1120/1/3. MAH: Wrafton Laboratories Ltd. (T/A Perrigo), Braunton, Devon, EX33 2DL, UK. RRP (ex. VAT): 10 €7.60 Date of preparation Apr 2018. http://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1120-001-003_14022018144055.pdf Perrigo Cold & Flu Multi Relief Capsules, Paracetamol 500 mg, Guaifenesin 200 mg, Phenylephrine 6.1 mg. For the relief of symptoms of colds and flu and the pain and congestion of sinusitis, including aches and pains, headache, blocked nose, sore throat, lowering of temperature, and to loosen stubborn mucus and provide relief from chesty coughs. Adults, the elderly and children aged 16 years and over: Two capsules every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. Do not give to children under 16 years. Not to be continued for over 3 days without consulting a doctor. Contraindications: Hypersensitivity to any of the ingredients, hepatic or severe renal impairment, hyperthyroidism, diabetes, heart disease, those taking tricyclic anti-depressants or beta-blockers, patients who are taking or have taken monoamine oxidase inhibitors within the last two weeks or those currently receiving other sympathomimetics, phaeochromocytoma, prostatic enlargement or urinary retention, closed angle glaucoma, and porphyria. Precautions: Circulatory disorders, asthma, may act as a cerebral stimulant. Do not take with alcohol. Pregnancy and lactation: Not to be taken during pregnancy or whilst breast feeding. Side effects (unknown frequency): Thrombocytopenia, agranulocytosis, anaphylaxis, cutaneous hypersensitivity, bronchospasm, hepatic dysfunction, acute pancreatitis. See SmPC for full list of side effects and further information. Legal classification: P. PA 1120/1/2. MAH: Wrafton Laboratories Ltd. (T/A Perrigo), Braunton, Devon, EX33 2DL, UK. RRP (ex. VAT): 16 €7.30. Date of preparation Apr 2018. http://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1120-001-002_09032018152037.pdf Perrigo Cold & Flu Powder for Oral Solution Paracetamol 500 mg, Guaifenesin 200 mg, Phenylephrine 10 mg. For the short-term relief of symptoms of colds and flu including aches and pains, headache, blocked nose, sore throat, chills and fever and to loosen stubborn mucus (phlegm) and provide relief from chesty coughs. Adults, the elderly and children aged 12 years and over: One sachet every 4-6 hours when necessary to a maximum of 4 sachets (4 doses) in a 24-hour period. Do not give to children under 12 years. Not to be continued for over 3 days without consulting a doctor. Contraindications: Hypersensitivity to any of the ingredients, hepatic or severe renal impairment, cardiovascular disorders, hyperthyroidism, diabetes, phaeochromocytoma, glaucoma, urinary retention, patients taking tricyclic antidepressants or beta-blockers, patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors, or those currently receiving other sympathomimetic drugs. Precautions: Circulatory disorders myasthenia gravis, severe gastrointestinal diseases, glucose-6-phosphatedehydrogenase deficiency, haemolytic anaemia, glutathione deficiency, asthma, those on a controlled sodium diet. Patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. May be harmful to people with phenylketonuria. May act as cerebral stimulant. Do not take with alcohol. Pregnancy and lactation: Not to be taken during pregnancy or whilst breast feeding. Side effects (unknown frequency): Thrombocytopenia, agranulocytosis, anaphylaxis, cutaneous hypersensitivity reactions, bronchospasm, hepatic dysfunction, acute pancreatitis. See SmPC for full list of side effects and further information. Legal classification: P. PA 1891/3/. MAH: Wrafton Laboratories Ltd. (T/A Perrigo), Braunton, Devon, EX33 2DL, UK. RRP (ex. VAT): 10 €5.15. Date of preparation Apr 2018. https://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1891-003-001_19022018162036.pdf Perrigo Cold & Flu Tablets, Paracetamol 250 mg, Guaifenesin 100 mg, Phenylephrine 5 mg. For the relief of symptoms of colds and flu, including aches and pains, headache, blocked nose, sore throat, chills and chesty coughs. Adults, the elderly and children aged 12 years and over: Two tablets every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. Children under 12 years: Not to be used unless recommended by a doctor. Not to be continued for over 3 days without consulting a doctor. Contraindications: Hypersensitivity to any of the ingredients, hyperthyroidism, diabetes, cardiovascular disorders, hepatic and renal impairment, patients who are taking or have taken monoamine oxidase inhibitors within the last two weeks, those taking tricyclic anti-depressants or those currently receiving other sympathomimetics, phaeochromocytoma, prostatic enlargement, urinary retention, glaucoma and porphyria. Precautions: Circulatory disorders, asthma, may act as a cerebral stimulant. Do not take with alcohol. Pregnancy and lactation: Not to be taken during pregnancy or whilst breast feeding. Side effects (unknown frequency): Agranulocytosis, thrombocytopenia, abnormal hepatic function, anaphylaxis, cutaneous hypersensitivity reactions, bronchospasm, acute pancreatitis. See SmPC for full list of side effects and further information. Legal classification: P. PA 1120/1/1. MAH: Wrafton Laboratories Ltd. (T/A Perrigo), Braunton, Devon, EX33 2DL, UK. RRP (ex. VAT): 16 €5.40. Date of preparation Apr 2018. http://www.hpra.ie/img/uploaded/swedocuments/ LicenseSPC_PA1120-001-001_06022018104036.pdf.


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Benzydamine hydrochloride/Cetylpyridinium chloride Septabene lozenges and spray: The spray solution and lozenges contain benzydamine hydrochloride and cetylpyridinium chloride. Septabene spray: Indicated for adults and children aged 6 years and over for anti-inflammatory, analgesic and antiseptic treatment of irritations in the throat, mouth and gums, in gingivitis, pharyngitis, laryngitis and before and after tooth extractions. Septabene lozenges: Indicated for anti-inflammatory, analgesic and antiseptic treatment of symptoms of sore throat associated with upper respiratory infections including pharyngitis, laryngitis and tonsilitis. Children from 6 to 12 years of age: The recommended dosage is 3 lozenges a day. The lozenge should be slowly dissolved in the mouth every 3-6 hours. For a single dose of the spray, press the spray head once. This may be repeated every 2 hours 3-5 times a day. Adults, elderly and children over 12 years of age: The recommended dosage is 3-4 lozenges a day. The lozenge should be slowly dissolved in the mouth every 3–6 hours. For a single dose of the spray, press the spray head once to twice. This may be repeated every 2 hours 3-5 times a day. Precautions: Septabene should not be used for more than 7 days. If there is no improvement after 3 days, the patient should consult a doctor. The use of topical preparations, especially over a long period of time, may lead to sensitization, in which case the treatment must be discontinued and doctor consulted to set up a suitable therapy. Septabene must not be used in combination with anionic compounds, such as those present in toothpastes, therefore it is not recommended to use the product immediately before or after cleaning teeth. Benzydamine use is not advisable in patients with hypersensitivity to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other NSAIDs. Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients. Septabene should not be used in patients with open wounds or ulcerations in the mouth or throat. Septabene contains isomalt (E953). Patients with rare hereditary problems of fructose intolerance should not take this medicine. Direct contact of Septabene spray solution with eyes should be avoided. Septabene spray contains small amounts of ethanol. Contraindications: Septabene lozenges and spray: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the SPC. Children aged under 6 years: The pharmaceutical form is not appropriate for this age group. Fertility, pregnancy and lactation: There are no or limited amount of data from the use of benzydamine hydrochloride and cetylpyridinium chloride in pregnant women. Septabene is not recommended during pregnancy. It is unknown whether benzydamine hydrochloride (metabolites) are excreted in human milk. A risk to the newborns and infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue (abstain from) Septabene therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Adverse reactions: Septabene lozenges and spray: Rare: Hypersensitivity reaction, bronchospasm, urticaria, photosensitivity. Very rare: Oral mucosal irritation, burning oral sensation. Not known: Burning mucosa, anaesthesia of oral mucosa. Shelf life: 2 years. Legal category: Medicinal product not subject to medical prescription. Marketing authorisation number: Septabene spray PA1347/049/001, Septabene lozenges PA1347/063/001. Marketing authorisation holder: Krka, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. SPC: http://www.hpra.ie/homepage/medicines/medicines-information/ find-a-medicine/results?query=septabene&field= Date of preparation: June 2017. Additional information is available on request from Krka Pharma Dublin Ltd. Unit 4A, Leopardstown Business Centre, Ballyogan Road, Leopardstown, Dublin 18. D18 KX88. Reference number: 01-02-2018.


Special Report Poll suggests majority of Irish pharmacists are not prepared for Falsified Medicines Directive In this issue, we return to the Falsified Medicines Directive (FMD) to discover how prepared Irish and other authorities are for the compliance deadline next February. Having covered the global rationale for stricter controls in part one, part two of Irish Pharmacy News’ three-part special on FMD will narrow the focus to the local context. a duty to comply with: action is required now to be ready on time. “Pharmacists have been notified via a number of different channels since the start of 2018, from both the Pharmaceutical Society of Ireland (PSI) and the Irish Pharmacy Union (IPU), and we will ramp up communications from IMVO shortly and will continue them up until next February. Registration will open up during the week commencing 22nd October and we will contact pharmacies directly with details of how to register with IMVO. It is very important that people know they must have decided which software provider they will be using before they begin the IMVO registration process and this is something they can be working on now."

An IPN online poll has suggested that many pharmacists are unprepared for the introduction of the FMD Falsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they have not been properly checked for quality, safety and efficacy, as required by strict EU authorisation, they can pose a real risk to your health. As falsified medicines become more sophisticated, the risk of them reaching patients in the EU increases. They represent a serious threat to global health and call for a comprehensive strategy both at European and international level. The FMD will introduce a system to track legitimate medicines from manufacturers to patients. Manufacturers will be obliged to apply safety features to each pack: a tamper-proof security seal and a 2D barcode. The barcode enables each pack to be serialised with a unique randomised number, which will be authenticated before dispensing. Manufacturers will check packs into the database and they will be authenticated, decommissioned or “checked out” in the pharmacy by scanning the barcode. This sends a message to the database, which

then considers the authenticity of that pack, sending confirmation back to the pharmacy. There are just three full months (bearing in mind the Christmas break) left for all actors in the supply chain to achieve compliance, and questions are arising about preparedness. IT suppliers warned pharmacies in early October that delaying could result in non-compliance, extra fees, and possible late delivery of essential equipment. The general consensus is that doing nothing is not an option. Over a weekend in October, IPN ran a survey on a number of social media platforms used regularly by pharmacists, technicians, and other people connected to community pharmacy. • Sixty-five percent of respondents said their community pharmacy team is “neither informed nor prepared” for the upcoming February 2019 compliance deadline. • Just over 33 percent felt that their team was informed but not prepared.

• Of the 169 people polled, just two people, representing 1.2 percent of respondents, said they were both informed and prepared. • The results mean that cumulatively, over 98 percent of respondents consider themselves to be unprepared for the changes. The IPN poll results broadly support the view that most community pharmacy teams are under-informed and under-prepared. Irish Pharmacy News spoke to Leonie Clarke of the Irish Medicines Verification Organisation (IMVO) and asked if these numbers are concerning. She said: "We need to be careful about extrapolating from a series of small online and personal polls, particularly where there is no way of knowing who all the respondents were. That said, it is vital to ensure that there is widespread understanding amongst community pharmacists that this is a piece of medicines legislation that everybody has

Clarke shares her unique insight into the on-going preparations. “We are very busy and it has turned out across Europe to be far more complicated than anyone had previously envisaged, and that applies to every aspect of it. The complications are not arising so much on the pharmacy side, but more so from the point of view of manufacturers getting their systems connected and their data uploaded. This has been a huge learning curve for everyone. In terms of pharmacies, the compliance requirements are somewhat simpler, but it is important to emphasise that while people are waiting to hear from the IMVO with details on how to register with us there are a number of things they can be getting on with to make the transition smoother. For example, pharmacies need to start to think about where they are going to decommission packs, and should also be doing some research into which system they are going to use. “When pharmacists do hear from IMVO, we would be urging them not to wait until the last minute to register with us. There are

PHARMACYNEWSIRELAND.COM | 21


Special Report and wholesaler systems request similar permissions from us and from there develop the connection to our system. Once they get the go-ahead, pharmacies and wholesalers can connect to the IMVO repository.”

Leonie Clarke from the IMVO

approximately 1,800 pharmacies in the country so if 1,000 of them wait until January then it is going to be a very busy month. A key message we want to get out there is that doing nothing is not an option: pharmacists need to be thinking about this and starting to plan for it now.” Clarke goes into more detail about what pharmacists can expect when they begin the IMVO registration process. “People register with us online and when they do, we will check to make sure they are a legitimate organisation with an entitlement to be connected to the system, so for example we would look to see if the pharmacy is registered with the PSI, and then once they have passed that legitimacy check, we will then provide them with the codes they will need. The companies providing the pharmacy

Clarke explains what preparations are being undertaken directly by the IMVO. “The Irish repository is live and has been up and running since April. As the year has gone on, we have been rolling out more functionality in the system so it is very much an ongoing process. When we ran the pilot in community pharmacy, we basically started hooking up a small number of pharmacies, wholesalers and IT software providers, so we could actually start to see people scanning the packs in practice. We have learned from the pilot and refined some of our own procedures. We ran a training programme for pharmacists as part of that and we have modified them to take account of the feedback we have received and training webinars will be made available. Similarly, we have anticipated some of the problems that may arise on the ground and the webinar training will cover many of these issues and will explain to pharmacists how they can be avoided. It is also a case that this is a very complex change and so our plan is to provide pharmacies, and everyone else who is connected to the system, with a support matrix that will set out contact in that event.”

British neighbours in community pharmacy, who have recently been told by the MHRA, the UK medicines regulator, that the FMD directive will not apply in the event of a ’No-deal’ Brexit. Despite the warning, pharmacists must still prepare for compliance. Chief executive of the Company Chemists’ Association (CCA), which is the organisation representing the largest multiples, Malcolm Harrison has drawn attention to the expense that pharmacies in the UK are being expected to absorb, with no guarantee that the Directive will apply to them post-Brexit. “We agree with the FMD Working Group that the government must be open and transparent with the pharmacy sector. This is to ensure that community pharmacy, which is already financially challenged, is not required to invest in FMD systems if they will not be needed in the future. If community pharmacies remain required to

comply with these new aspects of the Directive, we believe the additional cost burden should be taken into account within any new NHS funding settlement. In the event of the UK medicines verification system being disconnected from the European hub after Brexit, we similarly agree with the FMD Working Group that the government should fully compensate the sector, where all or part of the system which has been invested in becomes redundant.” Belgium, Greece and Italy have an additional six years to comply with the directive as they already have serialisation procedures in place. To share your views on how the changes will affect Irish community pharmacies, and to contribute to part three of our Falsified Medicines Directive special, please email: editorial@ipnirishpharmacynews.ie

Brexit and FMD As complex as the changes may seem, they are is proving to be even more complex for our

Malcolm Harrison, Chief Executive of the CCA

CarePlus Pharmacy hosted their much anticipated Annual Conference 2018 in The Lyrath Kilkenny with a stellar line up of international speakers and Business Excellence Awards hosted by Lucy Kennedy Full coverage of the event in Dynamic 100 issue

22 | PHARMACYNEWSIRELAND.COM

From left: Matt Cooper, Clare Dillon, Dr Dominic Hegarty, Stephen Kinsella, John Carroll (Axium) and Paul Lavery (McCann Fitzgerald)


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Feature Community pharmacists’ role in educating patients about the effects of Crohn’s Disease What is Crohn's Disease? Crohn's disease is a rare, chronic condition that causes inflammation and ulceration of the lining of the digestive system. According to the HSE, the inflammation usually occurs in the ileum (the last section of the small intestine) or the colon (the large intestine). However, inflammation can occur anywhere in the digestive system, from the mouth to the anus. The inflammation that is caused by Crohn's disease can, over time, damage sections of the digestive system, causing additional complications, such as narrowing of the colon. What causes Crohn’s Disease? The exact cause of the disease is unknown, but research suggests a combination of environmental and genetic factors is responsible for the onset of Crohn's. The disease is most common in westernised countries, such as Ireland. It’s estimated that for every 100,000 people, seven new cases of Crohn's Disease will be diagnosed each year. Most new cases develop in people who are aged between 16 and 30, and Crohn's Disease affects slightly more women than men. The disease is particularly aggressive in children. The Irish Society for Colitis and Crohn’s Disease says there are about 40,000 people in Ireland living with Inflammatory Bowel Disease, an umbrella term used to describe Crohn’s Disease and ulcerative colitis. “The peak incidence of these diseases is between the ages of 15 to 35, with a second peak incidence between the 50s and 70s,” it said. “The diseases can be particularly aggressive in children and we have seen a 90% increase in cases of childhood IBD in Ireland between 2002 and 2012.” What are the symptoms of Crohn's Disease? The most common symptoms of Crohn's Disease are recurring diarrhoea, abdominal pain and cramping (which is often worsened after eating), blood and mucus in faeces, weight loss, chronic fatigue, and malabsorption of essential nutrients. Less common symptoms of the condition include

The exact cause of Crohn's Disease remains unknown fever, nausea, vomiting, joint pain, eye swelling or irritation and skin rashes. A 2011 pan European survey of people with Crohn’s disease and ulcerative colitis found more than than 90% of patients in Ireland had been hospitalised in the previous five years, and that the condition had a negative impact on their education, career and relationships. How is the condition diagnosed? No single test can be used to diagnose Crohn's Disease, so patients often have to undergo a series of tests before the condition can be confirmed. The most common tests used to diagnose Crohn's Disease are blood tests, stool samples, colonoscopies, small bowel enemas, x-rays and, in some cases, biopsies. How is Crohn's Disease treated? The outlook for Crohn's disease varies from patient to patient. Some people have long periods of remission - lasting for weeks or months - where they have very mild or no symptoms at all, followed by flare-ups. Others suffer with the condition on a day-to-day basis. There is no cure for Crohn's

24 | PHARMACYNEWSIRELAND.COM

disease, but some medications can help treat symptoms and prevent them from returning. “There are a variety of medications used to treat Crohn’s disease,” said Blaithin Arnold, a clinical trials pharmacist at the National Children’s Research Centre. “The aim of treatment is to reduce inflammation in the gut to bring relief from symptoms and ultimately induce remission of disease. Once under control, the doctor may continue to prescribe medications to maintain remission and prevent relapse.” About eight in 10 people with Crohn's disease will need to have surgery at some point to relieve symptoms, repair damage to their digestive system, and treat complications. The Irish Society for Colitis and Crohn’s Disease says surgery often involves the removal of part or all of the intestine and/or rectum, and can lead to the use of a stoma appliance. Types of treatment for Crohn's Disease include: • steroids, such as budesonide and prednisolone, to reduce inflammation • aminosalicylates, such as sulfasalazine, can be used as an alternative to steroids in mild cases of Crohn's Disease

• immunosuppressants, such as azathioprine and mercaptopurine, which are often used in combination with steroids when the patient has a relapse • biological therapies, including infliximab (usually only recommended in more severe cases) and adalimumab • surgery (removing the inflamed section of the digestive system) is often required when the symptoms of Crohn's Disease cannot be controlled using medication alone How can community pharmacists help? Blaithin Arnold, who also sits on the board of the Irish Society for Colitis and Crohn's Disease, said pharmacists often act as the first point of care for patients. “They play an active role in educating patients and providing a reliable source for information on Crohn’s disease management,” she said. “They can counsel patients on the potential side effects of their medications and the importance of taking them exactly as prescribed. Patients can always ask their pharmacist for advice before taking any over-the-counter medicines. Patients may need to be careful


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Feature taking some over-the-counter medicines if they have Crohn's disease. Some can worsen their symptoms, for example painkillers like ibuprofen can exacerbate people's symptoms.” There is no evidence that diet causes Crohn's Disease, but some patients report that certain foods aggravate their symptoms (including dairy products, alcohol, spicy foods, fatty foods, and highfibre foods). Pharmacists could recommend that patients keep a food diary to monitor how their diet may affect their symptoms. Vitamin and food supplements may be recommended if the patient is unable to eat certain foods, such as dairy products.

Pharmacist Blaithin Arnold, who sits on the board of the Irish Society for Colitis and Crohn's Disease

Smoking is the most important risk factor for Crohn's Disease aside from family history and ethnic background, with smokers twice as likely to develop the condition compared to nonsmokers. The HSE says smokers with Crohn's

Disease also tend to experience more severe symptoms. Pharmacy smoking cessations programs, offered in tandem with other treatment, may be beneficial to patients suffering from Crohn's Disease. According to the Irish Society for Colitis and Crohn’s Disease, nonsteroidal antiInflammatory drugs, such as Ibuprofen, can increase the risk of a flare up. The group advises patients to discuss the risks with their GP before taking any over-the-counter drugs in this category. Patients are advised to seek medical advice if they: • experience persistent diarrhoea that is not alleviated by over-the-counter medications • suffer from persistent abdominal pain • experience unexplained weight loss • notice blood in their faeces

News Employers urged to support employees to get vaccine and stay healthy this winter Employers are being encouraged to facilitate and support employees ahead of winter by signposting and providing information about where they can get the seasonal influenza vaccine. Flu can have a significant impact on Ireland's business community and economic productivity and for small and medium-sized enterprises (SMEs) in particular, an outbreak of flu can quickly spread to all employees and undermine a company's performance and profitability. For many businesses, the flu season also coincides with the busy Christmas trading period. Commenting at the launch, Managing Director of Meagher's Pharmacy Group Oonagh O’Hagan said: "Vaccinations are the most effective way of preventing the flu. I encourage employers and business owners to lead by example and think about promoting a healthy workplace and putting staff wellbeing at the forefront by helping to keep the flu at bay this winter. A healthier team not only makes for a happier work environment but also will maintain productivity, reduce disruption on workload while colleagues are out sick, and limit the risk of spreading it to their families and friends." Research from Canada found that employee absenteeism due to flu typically ranged from 5 percent to 20 percent, with higher rates associated with multiple flu strains circulating, as was the case last year in Ireland. The new #FluFree campaign was developed with pharmaceuticals company Mylan, who are leading suppliers and experts in flu vaccinations across the globe. Wider immunity is important as it protects vulnerable

people who are at a higher risk of developing sometimes lifethreatening complications, and last year was a particularly bad flu season, in terms of longevity. Every flu season puts a strain on the healthcare system, and last year’s figures indicate that 4,680 patients were hospitalised due to influenza during the 2017/2018 season. Retail Excellence CEO Lorraine Higgins and also encouraged increased uptake of the vaccine. "When you see that the overwhelming level of short-term absences is due to things like colds and flu, it is clear that preventative measures need to be a focus for Irish business. We know the cost of losing productivity from staff being out sick in general has amounted to over ¤1bn per annum (that's approximately ¤818 per employee) which can be damaging to business objectives and the development of SMEs. Therefore, providing information on the flu vaccine and encouraging staff to avail of it is a more effective and economic approach to safeguarding their wellbeing and your business."

26 | PHARMACYNEWSIRELAND.COM

Lorraine Higgins, CEO of Retail Excellence, Owen McKeon, Country Manager Mylan Ireland and Oonagh O'Hagan, Meaghers Pharmacy Group. Mylan's Country Manager Owen McKeon, said "Not only are vaccinations the best way to protect against catching and spreading flu, they also provide a means to reducing the increase of

antimicrobial resistance in Ireland. By proactively safeguarding against the flu, patients can limit their reliance on antibiotic medicines and take more control over their health this winter.”


Suspension for injection. Influenza Vaccine (Surface antigen, inactivated)

PRESCRIBING INFORMATION INFLUVAC SUB-UNIT, SUSPENSION FOR INJECTION Refer to the Summary of Product Characteristics for full information Presentation: Influenza vaccine (surface antigen, inactivated) containing the purified haemagglutinin and neuraminidase antigens prepared from the A and B influenza virus strains recommended by WHO. Indication: Prophylaxis of influenza, especially in those who run an increased risk of associated complications. Adults and children from 6 months of age. Dosage and Administration: Adults and children from 36 months: 0.5 ml. Children from 6-35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml may be given. Children not previously vaccinated require a second dose after an interval of at least 4 weeks. Children less than 6 months: safety and efficacy in children less than 6 months have not been established. No data available. Immunisation should be by intramuscular or deep subcutaneous injection. Contraindications, Warnings, Precautions etc: Contraindications: Hypersensitivity to active substances or excipients (see SPC) or to any components present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin. Postpone immunisation in patients with febrile illness or acute infection. Warnings /Precautions: Appropriate medical treatment and supervision should be available in case of an anaphylactic event following administration. Not to be administered intravascularly. Anxietyrelated reactions including vasovagal reactions (syncope), hyperventilation or stress-related reactions can occur following, or even before vaccination as a psychogenic response to the needle injection, Can be accompanied by several neurological signs

such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. Important that procedures are in place to avoid injury from faints. Antibody response may be insufficient in patients with endogenous or iatrogenic immunosuppression. Interference with serological testing.

paraesthesia, febrile convulsions, neurological disorders such as encephalomyelitis, neuritis and Guillain Barré syndrome. Vasculitis associated in very rare cases with transient renal involvement. Generalised skin reactions e.g. pruritus, urticaria, non-specific rash.

Pregnancy, Lactation, Fertility: Can be used in all stages of pregnancy. Larger datasets on safety are available in the second and third trimester compared with the first trimester, however data from worldwide use of influenza vaccine do not indicate adverse foetal and maternal outcomes. May be used during breastfeeding. No fertility data is available.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/ risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: + 353 1 6762517. Website: www.hpra.ie. E-mail: medsafety@hpra.ie. Adverse events should also be reported to Pharmacovigilance, Mylan, Building 4 – Trident Place, Hatfield Business Park, Mosquito Way, Hatfield, Hertfordshire, AL10 9BW, phone no: +44 (0) 800 121 8267, Email: UKPharmacovigilance@mylan.com.

Ability to Drive and Operate Machinery: Influvac has no or negligible effect on the ability to drive and use machines.

Marketing Authorisation Holder/Number: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK. PA 2136/2/1 Legal Category: POM

Side-effects: Headache, sweating, myalgia, arthralgia, fever, malaise, shivering, fatigue.

Further Information is available from: Mylan IRE Healthcare Limited, Newenham Court, Northern Cross, Malahide Road, Dublin 17.

Drug Interactions: Influvac may be given at the same time as other vaccines, but separate limbs should be used and adverse reactions may be intensified. Following influenza vaccination, false positive results in serology tests using the ELISA method to detect HIV1, Hepatitis C and HTLV1 antibodies have been seen. Immunological response may be reduced in patients on immunosuppressant treatment.

Local reactions: redness, swelling, pain, ecchymosis, induration. Transient thrombocytopenia, transient lymphadenopathy, allergic reactions in rare cases leading to shock, angioedema. Neuralgia,

PI/2/2/1002 Date of preparation: August 2018 Job code: INF-2018-0115


News New drug offers hope to hair loss sufferers as one in eight report worrying about condition One in eight people are worried about hair loss, either because they are currently experiencing the condition or they fear it might occur in the future, according to new findings. And more than one in eight respondents said it would badly affect their confidence and selfesteem. Over half of this group were women (55.5%) while more than a quarter were aged between 25 and 34 (26.6%). The findings come as researchers make a discovery that could have significant implications for the treatment of hair loss.

Cormac Loughnane, superintendent pharmacist at McCabes Pharmacy

In a survey commissioned by McCabes Pharmacy, 17.5% admitted feeling worried by the overall effect of hair loss or more specifically the effect it might have on their looks.

A recent study from the University of Manchester’s Centre for Dermatology Research found that a drug typically used as a treatment for osteoporosis has a dramatic effect on human hair follicles. By using the scalp hair follicles of hair transplant patients, the laboratory team discovered that a compound within the immunosuppressive drug cyclosporine A appears to remove an inbuilt ‘brake’ on human hair growth. Lead researcher Dr Nathan Hawkshaw said the finding

was “exciting because of its translational potential”, adding that it “could one day make a real difference to people who suffer from hair loss”. However, a clinical trial will be needed to determine the safety and efficacy of the drug. Hair loss is thought to affect around 50% of women, with 40% of men seeing noticeable balding by age 35 and 65% by age 60. According to one hair loss treatment centre, 60% of those affected by the condition would rather have more hair than money or friends. Cormac Loughnane, superintendent pharmacist at McCabes Pharmacy, said: “There’s no doubt that losing your hair can be highly traumatic. And with a number of possible causes, including heredity, hormonal changes, medical conditions and certain medications, it can leave the sufferer feeling helpless,

anxious and depressed, as our survey findings suggest. “The new research from the University of Manchester is certainly encouraging and will give hair loss patients hope that a viable treatment could be on the horizon, providing an alternative to costly and invasive hair transplant procedures.” In addition to the cost of hair transplants, which can range from ¤1,000 to ¤30,000, there are risks associated with the procedure, according to the Health Service Executive, including excessive bleeding and infection. Mr Loughnane added: “With clinical trials for the new drug compound yet to take place, the treatment could be a long way from public reach. Fortunately, in the meantime there are now a number of safe and effective over-the-counter treatments that hair loss sufferers can try and at a fraction of the cost of surgical measures.”

Award nomination recognises friendliness and customer focus in Mayo pharmacy O'Donnell's totalhealth Pharmacy is a family-run business located in County Mayo. Run by husband and wife team Nuala and Ian, with two premises in Charlestown and Swinford, the business has been operating for over 50 years. Recently their hard work and dedication was rewarded by being nominated in the JCI Friendly Business Awards. These awards seek to recognise and celebrate businesses that go the 'extra mile' by continuing to enhance the customer experience without compromising on customer service. JCI is an international, non-profit, voluntary organisation focusing on four pillars of opportunity: individual, business, community and international. Finalists O'Donnell's totalhealth Pharmacy were credited for their social media focus. Karena Finn is in charge of digital content for the two pharmacies. "It is all about keeping our customers updated. We let them know about offers, events, important seasonal reminders (like flu vaccination), so it's easy for them to arrange a visit to the pharmacy. Our customers are like family, so they are really proud of our achievements."

The O'Donnell's totalhealth Facebook page gets a lot of customer interaction, and more recently experienced a spike in activity with customers wishing to congratulate the O'Donnell's on their recent nomination. Finn puts their success down to planning and focus. "You need to keep on top of your social media, keeping the whole team involved. We make a plan at the start of the week so that we can be more efficient. And it's so important to respond to your customers as soon as possible – it's a great way to interact with them, gather feedback and get new ideas." The couple also owns and operates Nature's Garden health food store in Swinford. They are part of the totalhealth pharmacy group, a network of over 70 independent pharmacies who have come together to offer better value and choice to their customers.

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Munaza Gilmore (JCI Mayo President), Nuala O'Donnell MPSI (owner O'Donnell's totalhealth), Karena Finn (Business Manger O'Donnell's totalhealth), Ian O'Donnell MPSI (owner O'Donnell's totalhealth), Laura Enache (JCI Ireland President)


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News Legislation suggests pharmacists will have no role in abortion services The Irish Pharmacy Union has said that legislation published regarding abortion provision suggests that pharmacists will have no involvement in the service. requires pharmacists to ensure that in instances where they are unable to provide prescribed medicines or pharmacy services to a patient they must take reasonable action to ensure these medicines/services are provided and the patient’s care is not jeopardised. “As such, a pharmacist who, for religious or ethical reasons, cannot provide a specific service to a patient must direct that patient to someone who will.”

The IPU had written to the Health Minister Simon Harris earlier this year to ensure that provisions for healthcare professionals to conscientiously object to prescribing medicines for termination should be extended to pharmacists.

He said the IPU had written to the Minister for Health Simon Harris last February “requesting that any provisions to allow for GPs to conscientiously object to prescribing medicines for termination should be extended to all healthcare professionals, including pharmacists, in order to ensure that individual practitioners would not be compelled to participate in a procedure to which they have fundamental religious or ethical objections.”

A spokesman said their code of conduct “already provides for conscientious objection but

However, “now the legislation has been published, Section 13 would seem to suggest that the

Health Minister Simon Harris

GP supplies the medicines as part of the consultation and there does not seem to be any involvement of pharmacists in the service,” he said. Meanwhile the Department of Health is to meet medical colleges including the Irish College of General Practitioners, the Royal College of Physicians, and the Institute of Obstetricians and Gynaecologists to discuss clinical protocols to deliver an abortion service, a spokeswoman for the Irish Medical Organisation has said. It is the largest medical representative body and trade union in Ireland. It was “important that medical professionals can, on a conscientious basis, choose not to deliver this service,” she said. “The organisation expects that given the deeply held views which exist on this issue, the legislation will create a system which facilitates access to abortion services by women while also catering for medical professionals who have deeply

held conscientious objections on this matter,” she said. A spokesman for the Irish Nurses and Midwives Organisation (INMO) said they support freedom of conscience on the issue. “The current Protection of Life During Pregnancy Act also contains such provisions, and the proposed bill makes similar provision, and we are seeking that the current protections will apply in the future,” he said. Dr Edward Mathews, INMO Director of Professional and Regulatory Affairs, said “the right to conscientious objection on various matters has long been part of the professional code of nurses and other health professionals, and it was also recognised in the Protection of Life During Pregnancy Act. “Similar protections are contained within the proposed bill, and we look forward to working with the Government and employers to ensure that this right is secured in upcoming legislation and in practice in individual workplaces.”

Death of pioneer of nicotine patches and founder of first Irish company to list on NYSE Don Panoz, founder of the Elan Pharmaceuticals group, the first Irish company to list on the New York Stock Exchange has died aged 83. Arriving in Ireland with a young family in 1969, Panoz, a 34 year old American pharmacist, set up a workshop in an outhouse of a rented bungalow in Monkstown, Co Dublin to develop his ideas surrounding the transdermal delivery of medication which was to lead eventually to the globally famous nicotine patch.

company. Within three years, it was valued at more than $100 million.

Within a few short years, Panoz’s micro-firm, Elan Pharmaceuticals, was thriving, establishing a research and development facility at Athlone Institute of Technology (AIT).

Much later, after research-related and regulatory difficulties from 2002 onwards, Elan was to suffer catastrophic losses and to close, but Panoz had long departed the company by then, selling nearly all of his investment in 1996 to a group of Irish-based investors.

By 1981, Elan had 25 contracts with 16 different pharmaceutical companies internationally. A research company was founded in Georgia in the US, followed by the launch on Nasdaq in New York of a US subsidiary of the Dublinbased Elan Corporation, the very first listing on the NYSE of an Irish

In 1985, Elan opened its first major manufacturing base in Athlone, where its co-operation with AIT led to the opening also in that year of the Institute of Biopharmaceuticals there.

Don Panoz had first decided to relocate to this country after he had had a good-natured disagreement about business development with his life-long best friend and fellow entrepreneur Milas “Mike” Puskar, with whom he had set up

30 | PHARMACYNEWSIRELAND.COM

Don Panoz, founder of the first Irish company to be list on the NYSE his first pharma venture, Milan Pharmaceuticals, at White Sulpher Springs, West Virginia, in 1961. Panoz, aged just 25 at the time, became then the youngest ever chief executive of an American pharmaceuticals company. The company they founded eventually became Mylan Pharmaceuticals, now one of the world’s largest manufacturers of generic drugs selling an estimated 1,300 products in 140 countries worldwide.

Born into a very poor family in Ohio (although raised from an early age in West Virginia), his mother was Irish-American, his father a professional prize-fighting boxer, Eugenio Panunzio, a firstgeneration Italian-American, who later changed his name to the simpler Panoz. Don Panoz is survived by his wife of 63 years, Nancy (nee Hefner), and by his children Danny, Chris, Dona, Denna, Liza and Andrea.


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Product Launch

Irish customers now have more OTC analgesic options with Easolief DUO With health regulators around the world restricting access to products containing codeine in an effort to inhibit misuse, the announcement of a new codeine-free analgesic to the market will come as welcome news to Irish consumers. Manufactured by the company Clonmel Healthcare, Easolief DUO is an innovative new product containing both paracetamol and ibuprofen and is available over-the-counter and without prescription. The patented formula combines the two active ingredients to produce “significantly improved and effective pain relief” without the additional ingredient of codeine. Targeting short-term pain with no addictive ingredients enables people who are suffering from pain to get on with their day.

Clonmel Healthcare launched the new product recently at Hugh Lane Gallery, Dublin. Guests heard New Zealand native and creator of Easolief DUO, Dr Hartley Atkinson, Founder and Managing Director of AFT Pharmaceuticals, explain how Easolief DUO came about and the benefits of same. This was followed by a truly inspirational talk from Mark Pollock, international motivational speaker, explorer, and author from Northern Ireland who became the first blind man to race to the South Pole.

Clonmel Healthcare say that Easolief DUO provides 30 percent more pain relief than the same daily dose of paracetamol or ibuprofen alone and the onetablet dose contains 500mg of paracetamol and 150mg of ibuprofen in a single convenient, film-coated tablet.

are averse to taking codeinecontaining products, but who still require strong, reliable relief from pain. It also gives patients options before stepping their treatment up to non-steroidal anti-inflammatory drugs (NSAIDS) or opioids which include codeine and dihydrocodeine.

This product can be relied upon to produce effective results when the patient does not experience relief by using standard painkillers on their own. The powerful combination product will come as a relief to consumers who

Inventor and creator, Dr Hartley Atkinson, explains why patients will welcome this new product. “Combination products that traditionally use paracetamol or ibuprofen as the basic active

Martin Gallagher, Director of Marketing and Business Development at Clonmel Healthcare, Mark Pollock, Barry Fitzpatrick, Director of Sales, Clonmel Healthcare and Dr Hartley Atkinson pictured at the launch of Easolief DUO at Hugh Lane Gallery, Dublin

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ingredient often add an opioid drug like codeine to amplify the effect. However, an increasing number of countries are restricting the availability of codeine drugs because of their potential for misuse and abuse, which is why Easolief DUO is so innovative” he said. Dr Atkinson is the founder and managing director of AFT Pharmaceuticals. The New Zealand native has a Masters of Pharmaceutical Chemistry with distinction (1983) and doctorate in Pharmacology from Otago University (1989). Easolief DUO is also available as Combogesic™ in the United Kingdom, as Maxigesic™ in New Zealand (since 2009) and in Australia (since 2014) via AFT

Pharmaceuticals, who have also out-licensed the intellectual property to over 40 countries around the world. “Easolief DUO is a welcome addition to Clonmel Healthcare’s growing pain management portfolio, and offers a completely unique pain relief solution to the Irish market,” commented Jim Hanlon, CEO Clonmel Healthcare. “We are delighted to be launching this unique product in Ireland, and look forward to helping assist consumers with their pain management,” he continued. Easoief DUO is now available to order from the Clonmel Healthcare’s freephone order line on 1800 26 26 26.

Patrick O’Sullivan, Life Pharmacy Santry, Liam Daly, Clonmel Healthcare and Leva Virse, Life Pharmacy Santry pictured at the launch of Easolief DUO

Christy Canavan, Consumer Director, United Drug, Martin Gallagher, Director of Marketing and Business Development at Clonmel Healthcare, Steve O’Donoghue, Commercial Director United Drug Wholesale and Eugene Thorpe, Commercial Buyer Manager, Uniphar Group pictured at the launch of Easolief DUO at Hugh Lane Gallery, Dublin

Louise Mullen, Clonmel Healthcare, Ciaran Rooney, Manus McAleer Finglas and Michelle Larkin, Maple Pharmacy pictured at the launch of Easolief DUO

Jim Hanlon, CEO, Clonmel Healthcare , Dr Hartley Atkinson and Daniel Herrmann vice President Western European Markets Stada pictured at the launch of Easolief DUO at Hugh Lane Gallery, Dublin. Healthcare company Clonmel Healthcare launched the innovative, new pain relief tablet, Easolief DUO, combining Paracetamol and Ibuprofen, which is now available over the counter without prescription

Nathalie Kalo, Assistant Buying Manager, Boots Ireland, Louise Mullen Clonmel Healthcare and Sian Feeney, Healthcare Buying Manager ROI, Boots Ireland

PHARMACYNEWSIRELAND.COM | 33


Feature

Pharmacists praised for helping COPD patients breathe easy As winter sets in, health professionals and community groups are praising pharmacists’ contribution to the fight against Chronic obstructive pulmonary disease (COPD) - one of Ireland’s leading causes of death.

Pharmacists are a great help, particularly with advice on medication and proper use of inhalers

Anne Murphy from COPD Support Ireland COPD is an umbrella term used to describe lung diseases that cause limitations in lung airflow. The illness makes breathing difficult, resulting in extreme shortness of breath and tiredness after small amounts of physical activity. Official Department of Health statistics reveal an estimated 500,000 people in Ireland have COPD.

medication and proper use of inhalers,” Professor Tim McDonnell, consultant respiratory physician at St Vincent’s University Hospital told Irish Pharmacy News. COPD Support Ireland agreed: “The aim is to assist people to live with this illness and keep on top of it at home rather than having to go into hospital,” said spokeswoman Anne Murphy.

However, up to 250,000 people fail to be diagnosed with this debilitating illness that can be managed if caught early.

“We’re grateful to have many pharmacists helping us in a very practical way, coming in to our talks and giving hands on advice on how to properly work inhalers or take medication correctly.”

And pharmacists across the country are providing major support in the fight against COPD, often going out of their way to assist those suffering with the illness.

Early detection and good management of symptoms are key, as exacerbation of the disease can create a need for medical attention and attendance at emergency departments, said Prof McDonnell.

“Pharmacists are a great help, particularly with advice on

As the disease progresses, patients may experience

34 | PHARMACYNEWSIRELAND.COM

symptoms and flare-ups more often, resulting in GP and hospital emergency visits. Patients often need oxygen treatment and use a nebuliser (a mouthpiece enabling medicine to be taken in as a mist).

“Often their local chemist is the first stop for people with COPD,” said Ms Murphy.

The most common cause of COPD is smoking, but about 30 per cent of sufferers are not smokers, and the disease can be caused by genetic factors or other links including prolonged exposure to dust, pollution or fumes.

“Not being able to breathe properly can be really frightening both for those with COPD and those close to them.”

But despite efforts to raise awareness, Ireland has the highest rate of hospitalisation for COPD in the 35-member counties of the Organisation for Economic Co-operation and Development (OECD), almost double the average. And COPD is sparking a high rate of acute hospital admissions, warned Professor McDonnell. This is reflected worldwide, with COPD striking at least 384 million people, according to the World Health Organisation (WHO). Health officials warn it is set to be the third most common cause of death by 2020, ranked as one of the most disabling conditions in the world. The illness flares up more in winter, and COPD Support Ireland says pharmacists play a leading role in helping people to manage symptoms.

The illness can be terrifying for sufferers and their families, she said.

Ms Murphy urged people with COPD to reach out for help. Since being set up in 2013 the support network now runs over 20 branches across the country. Irish Pharmacy Union (IPU) President Daragh Connolly said anyone worried about symptoms should come forward. “We know that the earlier you seek help, the more effective the treatments will be,” said Mr Connolly, who runs a Waterford pharmacy. “Most importantly, if you think you have some of the symptoms of COPD and you smoke, you must try to stop immediately. Call into your local pharmacist for help and support.” Pharmacists are often on hand at information sessions run by COPD Support Ireland and this is a welcome contribution, said Ms Murphy. Professor McDonnell welcomed this effort and said it can help with early intervention.


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* Patients had at least one moderate or severe exacerbation in the previous 12 months. † salmeterol/fluticasone 50/500µg BID. ‡ Annual rate reduction of all exacerbations (mild/moderate/severe): ULTIBRO® BREEZHALER® vs salmeterol/fluticasone was 11%(RR:0.89, p=0.003). Annual rate reduction of severe exacerbations: ULTIBRO® BREEZHALER® vs salmeterol/fluticasone was 13% (RR:0.87, p=0.23). Ultibro Breezhaler▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions. ABBREVIATED PRESCRIBING INFORMATION Please refer to Summary of Product Characteristics (SmPC) before prescribing. Presentation: Ultibro Breezhaler 85mcg / 43mcg inhalation powder hard capsules containing indacaterol maleate and glycopyrronium bromide respectively and separate Ultibro Breezhaler inhaler. Indications: A maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Dosage and administration: Recommended dose is the inhalation of the content of one capsule once daily, administered at the same time of the day each day, using the Ultibro Breezhaler inhaler. Capsules must not be swallowed. No dose adjustment required in elderly patients, for patients with mild and moderate hepatic impairment or for patients with mild to moderate renal impairment. No data available for use in patients with severe hepatic impairment and should only be used in patients with severe renal impairment or end-stage renal disease requiring dialysis if the expected benefit outweighs the potential risk. No relevant use in the paediatric population. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings/Precautions: Not to be administered concomitantly with medicinal products containing other LABA’s or LAMA’s. Asthma: ♦ULTIBRO BREEZHALER SHOULD NOT BE USED FOR TREATMENT OF ASTHMA. Acute use: ♦Not indicated for treatment of acute episodes of bronchospasm. Hypersensitivity: ♦Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium. If signs suggesting allergic reactions occur (in particular, angioedema, difficulties in breathing or swallowing, swelling of the tongue, lips and face, urticaria or skin rash), treatment should be discontinued immediately and alternative therapy instituted. Paradoxical bronchospasm: ♦If paradoxical bronchospasm occurs, Ultibro Breezhaler should be discontinued immediately and alternative therapy instituted. Anticholinergic effects related to glycopyrronium: ♦To be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Patients with severe renal impairment: ♦Should only be used in patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, if the expected benefit outweighs the potential risk. These patients should be monitored closely for potential adverse reactions. Cardiovascular effects: ♦To be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with known or suspected prolongation of the QT interval or patients treated with medicinal products affecting the QT interval and in patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged. ♦LABA’s may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms, ECG changes. In case such effects occur, treatment may need to be discontinued. Hypokalaemia: ♦LABA’s may produce significant hypokalaemia in some patients, which has the potential to produce cardiovascular effects. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment which may increase the susceptibility to cardiac arrhythmias. Hyperglycaemia: ♦Inhalation of high doses of LABA’s may produce increases in plasma glucose. Upon initiation of treatment with Ultibro Breezhaler plasma glucose should be monitored more closely in diabetic patients. ♦Ultibro Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled. General disorders: ♦To be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to LABA’s. Excipients: ♦Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine. Pregnancy and Lactation: ♦Ultibro Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus. ♦Not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk. Use of Ultibro Breezhaler by breast feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant. Interactions: ♦Concomitant use is not recommended with beta adrenergic blockers, anticholinergics or sympathomimetic agents. ♦Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution. ♦Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-gp, does not raise any safety concerns given the safety experience of treatment with indacaterol. ♦No clinically relevant drug interaction is expected when glycopyrronium is co administered with cimetidine or other inhibitors of the organic cation transport. Adverse reactions: ♦Very common: upper respiratory tract infection. ♦Common: nasopharyngitis, urinary tract infection, sinusitis, rhinitis, hypersensitivity, hyperglycaemia and diabetes mellitus, dizziness, headache, cough, oropharyngeal pain including throat irritation, dyspepsia, dental caries, bladder obstruction and urinary retention, pyrexia, chest pain. ♦Uncommon: angioedema, insomnia, glaucoma, ischaemic heart disease, atrial fibrillation, tachycardia, palpitations, paradoxical bronchospasm, dysphonia, epistaxis, gastroenteritis, dry mouth, pruritus / rash, musculoskeletal pain, muscle spasm, myalgia, pain in extremity, oedema peripheral and fatigue. ♦Please refer to SmPC for a full list of adverse events for Ultibro Breezhaler. Legal Category: POM. Pack sizes: Cartons containing 10 capsules (1x10 capsule blister strips) and one Ultibro Breezhaler inhaler or 30 capsules (3x10 capsule blister strips) and one Ultibro Breezhaler inhaler. Marketing Authorisation Holder: Novartis Europharm Limited, Frimley Business Park, Camberley GU16 7SR, United Kingdom. Marketing Authorisation Numbers: EU/1/13/862/007 & 003. Full prescribing information is available on request from Novartis Ireland Ltd, Vista Building, Elm Park Business Park, Dublin 4. Tel: 01 2601255 or at www.medicines.ie Date of Revision of API Text: 13th December 2016. REFERENCES: 1. IQVIA, IRLP, Units, MAT May 2018. 2. Wedzicha JA et al. N Engl J med 2016;374:2222-2234. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. 3. Vogelmeier CF et al. Respir Res 2017;18:140. Efficacy and safety of direct switch to indacaterol/ glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. 4. Chapman KR, Hurst JR, Frent S, et al. Long-term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in COPD Patients (SUNSET): a Randomized, Double-Blind, Triple-Dummy Clinical Trial. Am J Resp Crit Care Med. 2018. ePub ahead of print. https://doi.org/10.1164/rccm.201803-0405OC. 5. Ultibro Breezhaler Summary of Product Charaterictics. www.medicines.ie. Accessed on July 2018. IE02/ULT18-CNF083a. Date of Preparation: July 2018.


Feature “It was during one hospitalisation in 2007 that a doctor mentioned that I had been diagnosed with COPD. That was the first I had heard of it. I knew nothing about COPD, but I soon learned that with this disease, your lungs are irreparably damaged.” After seeking help and education and joining a support group the man’s condition improved: “I did an eight week rehab pulmonary course …That was brilliant, I hadn’t felt as good in years and I kept improving every week.” Mr Connolly advised people with COPD to become aware of what triggers make their condition worse. “Your pharmacist can help you to better understand your disease and manage it so that you can avoid hospitalisation,” he said. “Most importantly, if you think you have some of the symptoms of COPD and you smoke, you must try to stop immediately. Call into your local pharmacist for help and support.”

IPU President, Daragh Connolly “We know that there are people living with COPD who have no idea that they have the disease and are therefore not being treated for it,” he said.

“They are able to check that inhalers and other devices are being used correctly as incorrect use is a recurring problem for many patients.”

“Many are slow to come forward, or dismiss symptoms as just being a cold. But COPD can be deadly and is one of the leading causes of acute hospital admissions.”

And pharmacists help with campaigns including encouraging those with COPD to get the flu vaccine at this time of year, she said.

Mr Connolly agreed and said pharmacists were often the first port-of-call for those with COPD symptoms.

The Irish Thoracic Society (ITC) has welcomed the progress being made on dealing with respiratory conditions, but is calling for further action to tackle COPD

“Pharmacists are important in helping identify undiagnosed COPD in a patient,” he said. “People who are regularly looking for over-the-counter cough remedies should be advised to seek further investigation.” COPD Support Ireland said pharmacists were providing much needed support. “We have great pharmacists on board, and they are often happy to attend a meeting where they enjoy having the opportunity to spend time with patients in a relaxed atmosphere,” said Ms Murphy Now, experts are urging anyone fearing they may have the illness to take the next step and visit their doctor to organise a simple, quick and painless lung check, known as a spirometry test. Early treatment can make a big difference.

Symptoms include shortness of breath, cough and sputum (phlegm) production. Treatment can help combat these, as well as slowing lung damage However, many with the disease end up in hospital, and COPD Support Ireland said this may be linked to a lack of early diagnosis as the illness often goes undetected or gets mistaken for a cold or flu, or just normal part of ageing. This was the case for one typical COPD patient who wrote about his experience: “I remember standing at the All Ireland Final 1991 when I felt this throbbing pain radiating out from my chest around my heart. I ended up in intensive care in Waterford hospital the following day and was there nearly a month.

36 | PHARMACYNEWSIRELAND.COM

COPD Support Ireland pointed out many experience the illness in different ways, depending on symptoms and severity. The illness can creep up slowly, meaning it can sometimes be several years before symptoms including coughing, wheezing and shortness of breath reach a point where people are forced to seek medical help. The disease often hits people in their 50s, and because of this, many think they are simply becoming slower and less fit with age.

“It can often be several years before symptoms reach a level that will make the sufferer go to the GP. Symptoms such as coughing, wheezing and shortness of breath are often attributed to getting older and many are reluctant to seek treatment,” said Professor McDonnell. Mr Connolly said although there is no cure for COPD there are actions that make it easier to live with the condition, and pharmacists can help with advice. Alongside smoking cessation, some treatments for COPD include: Inhalers: There are various types and devices available. Depending on the medication inside the inhaler, these will help make breathing easier by opening up the airways and treating flare-ups. Exercise: One of the most important treatments is exercise. Ask your healthcare professional about pulmonary rehabilitation and an exercise programme. Corticosteroids: These can be given to soothe the inflammation in your lungs and help you breathe easier. Antibiotics: COPD may make you more vulnerable to infection. Bacteria causing the infection can cause exacerbations. Antibiotics will help to eliminate the bacteria. Flu Vaccine: COPD can make you more vulnerable to infections like the flu and pneumonia. Seasonal vaccinations help prevent infections.

Your pharmacist can help you to better understand your disease and manage it so that you can avoid hospitalisation


ONLY

AN RO umeclidinium/vilanterol

HAS POSITIVE HEAD-TO-HEAD DATA

VS. ANOTHER ONCE-DAILY LAMA/LABA* 1 In symptomatic patients with moderate COPD *Anoro compared to tiotriopium/olodaterol showed statistical superiority on pre-specified secondary endpoint of trough FEV1 at 8 weeks in the Intent to Treat population. ITT population n=236 (180mL vs. 128 mL in trough FEV1; Difference 52ml (p<0.001, 95% CI:28,77). The primary endpoint of non-inferiority on trough FEV1 at Week 8 in the PP population was met. Non-inferiority was met for the primary endpoint at Week 8 in the PP population (n=227) (175mL Anoro and 122mL tiotropium/ olodaterol, 95% CI: 26, 80; p<0.001)1

An 8-week, randomised, open-label, two-period crossover in symptomatic patients with moderate COPD (post bronchodilator FEV1 70% and  50% of predicted value, mMRC2) and not receiving ICS at inclusion.1 COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; mMRC, modified Medical Research Council scale; ITT, intent to treat. COPD, FEV PP, ITT

Learn more by visiting: www.anoro.ie/headtohead Anoro Ellipta is contraindicated for patients who are hypersensitive to the active substances or to any of the excipients. Anoro is not indicated for the treatment of acute episodes of bronchospasm. Cardiovasular events, such as cardiac arrhythmias, may be seen after the administration of muscarinic receptor antagonists and sympathomimeticagents, including umeclidinium/vilanterol. Therefore, Anoro Ellipta should be used with caution in patients with severe cardiovasular disease.2

Anoro 55/22mcg is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)2

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Anoro

(umeclidinium bromide/vilanterol [as trifenatate]) Prescribing information (Please consult the full Summary of Product Characteristics (SmPC) before prescribing)

Anoro® 55/22mcg (umeclidinium bromide/vilanterol [as trifenatate]) inhalation powder. Each single inhalation of umeclidinium bromide (UMEC) 62.5 micrograms (mcg) and vilanterol (VI) 25mcg provides a delivered dose of UMEC 55mcg and VI 22mcg. Indications: COPD: Maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Dosage and administration: Inhalation only. COPD: One inhalation once daily of Anoro. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate and magnesium stearate). Precautions: Anoro should not be used in patients with asthma. Treatment with Anoro should be discontinued in the event of paradoxical bronchospasm and alternative therapy initiated if necessary. Cardiovascular effects may be seen after the administration of muscarinic receptor antagonists and sympathomimetics therefore Anoro should be used with caution in patients with severe cardiovascular disease. Anoro should be used with caution in patients with urinary retention, narrow angle glaucoma, convulsive disorders, thyrotoxicosis, hypokalaemia, hyperglycaemia and severe hepatic impairment. No dosage adjustment is required in renal or mild to moderate hepatic

impairment. Acute symptoms: Anoro is not indicated for acute episodes of bronchospasm. Warn patients to seek medical advice if short-acting inhaled bronchodilator use increases, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken. Interactions with other medicinal products: Interaction studies have only been performed in adults. Avoid ß-blockers. Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin). Anoro should not be used in conjunction with other long-acting ß2-adrenergic agonists or medicinal products containing long-acting muscarinic antagonists. Caution is advised with concomitant use with methylxanthine derivatives, steroids or non-potassium-sparing diuretics as it may potentiate possible hypokalaemic effect of ß2-adrenergic agonists. Fertility, pregnancy, and breast-feeding: No available data. Balance risks against benefits. Side effects: Common: Urinary tract infection, sinusitis, nasopharyngitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, constipation and dry mouth. Uncommon: Hypersenstivity reactions including rash, trenor, dysgeusia, dysphonia, atrial fibrillation, supraventricular tachycardia,

References: 1. Feldman G.J et al. Adv Ther 2017; 34:doi 10.1007/s12325-017-0626-4 2. Anoro Ellipta Summary of Product Characteristics. Available from: www.medicines.ie. Accessed: January 2018. ANORO ELLIPTA was developed in collaboration with

rhythm idioventricular, tachycardia, supraventricular extrasystoles and palpitations. Rare: Anaphylaxis, angioedema, urticaria, vision blurred, glaucoma, intraocular pressure increased, paradoxical bronchospasm, urinary retention, dysuria and bladder outlet obstruction. Marketing Authorisation (MA) Holder: Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS, UK. MA Nr: 55/22mcg 1x30 doses [EU/1/14/898/002]. Legal category: POM B. Last date of revision: July 2017. Job Ref: IE/UCV/0063/15 (4). Further information available on request from GlaxoSmithKline, 12 Riverwalk, Citywest Business Campus, Dublin 24, Tel: 01-4955000.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Anoro and Ellipta are registered trademarks of the GlaxoSmithKline group of companies

©2018 GSK group of companies. All rights reserved.

IE/UCV/0006/17a Date of Preparation: January 2018


News Manifesto issues call to action to place Ireland at forefront for speed of access to new medicines Pharmaceutical innovators have issued a call to action, through the ‘Manifesto for Better Health’, to place Ireland in the top seven European countries for speed of access to innovative medicines. standards of healthcare and catch the global wave of pharmaceutical innovation. Among the recommendations in the ‘Manifesto’ are: 1. Speed access. Place Ireland in the top quartile of European countries for access to innovative medicines. This would rank Ireland in the top seven of the EU-28 and in the top half of the ‘basket of 14’ used for pricing in the industry’s deal with the Government.

Aidan Lynch, President of the IPHA

The ‘Manifesto’, is a roadmap for improving Ireland’s healthcare system by making innovative medicines available earlier to patients and positioning Ireland as a global leader in the discovery and manufacture of life-changing treatments. It recommends joint actions with Government and other stakeholders in key areas like access to medicines, innovation policy and healthcare partnerships. The ‘Manifesto’ was launched by the Irish Pharmaceutical Healthcare Association (IPHA) which represents the international research-based pharmaceutical industry. It is set against a backdrop of a challenging reimbursement environment for pharmaceutical innovators, with many medicines facing significant delays getting to patients through an inefficient approvals process. Data gathered by IPHA shows that Ireland remains among the slowest countries in western Europe to make innovative medicines available to patients. Some of the medicines are made in Ireland but they are available in Europe before patients here can access them. The ‘Manifesto’ has nine recommendations, three in each Vision Pillar of ‘Access for All’, ‘Innovation Excellence’ and ‘Republic of Partnerships’, aimed at helping Ireland to raise

2. Boost funding. Create a predictable, multi-annual budgetary framework, with sustained, reasonable annual increases in funding for innovative medicines. This needs to be explored with payers based on ‘horizon scanning’ for new medicines on the way, as well as projected demand for existing treatments. 3. Fuel innovation. The Government, with the support of the Taoiseach, should publicly recognise the value of the pharmaceutical industry to Ireland, with concrete actions that can be pursued jointly by a formal partnership between policymakers and industry leaders. As a first step, a Chief Innovation Officer should be appointed at the Department of Health to plan how Ireland pursues new cures like gene therapy and cell therapy, and leverages data for personalised medicine. Data gathered by IPHA for the most recent quarterly bulletin, published in August, showed that 10 IPHA medicines, evaluated through the Health Technology Assessment process, were available, on average, in 12 of 14 EU countries but they were not routinely available and reimbursed for Irish patients. These 14 countries are used as a benchmark for calculating prices. Since August, progress has been made on approving some of these medicines but the overall pattern shows that Ireland still trails peer countries in western Europe on access. The ‘Manifesto’ calls out the short and long-term consequences of this scenario: the impact on mortality rates and, conversely, survival rates relative to European

38 | PHARMACYNEWSIRELAND.COM

standards, as well as quality of life, will be negative. The ‘Manifesto’ warns that, economically, there could be negative implications for Ireland, with timely access to medicines increasingly used as a criterion for decisions on major new investments. Aidan Lynch, the newly elected President of IPHA and the General Manager at GSK, said the ‘Manifesto’ sets out a partnership approach to linking the innovation needed to discover and manufacture medicines with the delivery mechanism required to get them efficiently to patients. “The international research-based pharmaceutical industry has a major stake in Ireland’s future. The medicines we make, jobs we provide, and lives we enhance are helping to transform Ireland’s society and economy for the better. As an industry, we do not claim to have all the answers. However, we are calling for a new era of partnership between industry and Government that speeds access to innovative medicines for patients, and recognises the pivotal role of innovation in building a better healthcare system for Ireland. “Market access remains a challenge. Medicines, some of them manufactured here, are getting to patients in other European countries before they are available to patients here. Irish patients deserve access to new innovative medicines at speeds at least comparable to our western European peers. We are benchmarked against 14 EU countries on pricing. It is reasonable to expect that our timelines for reimbursement are at least as good as those same 14 countries,” said Mr Lynch.

invested in by industry, has allowed Ireland to attract investments of scale across many sectors, including in pharmaceuticals. By maintaining and improving the policy environment, our industry is confident Ireland can continue to attract investments that create sustainable, high-quality jobs, strengthen our manufacturing base, and prompt the development of advanced therapies.”

The international research-based pharmaceutical industry has a major stake in Ireland’s future

Ireland hosts all the top 10 pharmaceutical companies in the world. Over the past 10 years, the industry has invested close to ¤10 billion in manufacturing and research sites around the country. In 1988, just 5,200 people worked in the pharmaceutical industry. Today, foreign-owned pharmaceutical companies directly employ 30,000 people, with about as many more working in spin-off jobs. Matt Moran, Director of BioPharmaChemIreland, said: “The enterprise policy environment, created by the Government and

Matt Moran, Director, BioPharmaChem Ireland


CPD 96: MEDICINES OPTIMISATION IN CARE HOMES Biography - Amy Louise Oates qualified from the Robert Gordon University Aberdeen with a Master in Phamacy in 2011. She then undertook a pre-registration year with Gordons Chemists in Edinburgh. After registration she moved back home and worked for Johnstons Pharmacy in Longford Town, Lanesborough and Ballygar, Co. Galway. She has also completed a Cardiology in Clinical Pharmacy Practice module with Trinity College Dublin.

Reflection - Is this area relevant to my practice? What is your existing knowledge of the subject area? Can you identify any knowledge gaps in the topic area? Planning - Will this article satisfy those knowledge gaps or will more reading be required? What resources are available? Action - After reading the article complete the summary questions at www. pharmacynewsireland.com/cpdtraining and record your learning for future use and assessment in your personal log. Evaluation - How will you put your learning into practice? Have I identified further learning needs?

60 second summary Medicines optimisation is about ensuring that the right patients get the right choice of medicine, at the right time. Optimising a person's medicines is important to ensure a person is taking their medicines as intended and can support the management of long-term conditions, multi-morbidities and polypharmacy. The 4 main principles to Medicines Optimisation aim to ensure all patients are more engaged and understand more about their medicines reduce hospital admissions due to adverse side effects and make medicine optimisation part of routine practice. Prescribing for elderly patients can be very complex and special care should be given to the use of benzodiazepines, psychotropic medications and other medications that can increase the risk of falls. Through regular medication review pharmacists should aim to work more closely with their care homes and other healthcare professionals to improve both the safety and effectiveness of medicines and residents’ quality of life.

Medicines optimisation in care homes Medicines Optimisation in Care Homes Private and voluntary nursing homes play a key role in healthcare delivery in Ireland. Over 400 nursing homes provide expert care to almost 22,000 patients in specialist settings in local communities. Both private and voluntary nursing homes are meeting the growing care requirements of our ageing population. An ageing population is more likely to have multiple long-term conditions, meaning demand on care homes is likely to increase. Medication management systems in care homes can be complex, with clinical interventions from multiple sources and medicines dispensed from multiple sites. Optimising medicines use in care homes involves discussing the problems such as polypharmacy, inappropriate prescribing and lack or resident involvement in decisions about medicines. Up until recently regulation, guidance and national standards focused on care homes having policies and procedures in place to ensure safe medicines management. Now, the emphasis has moved to medicines optimisation, a patient outcome-focused approach to safe and effective use of medicines, taking into account the patient’s values, perception and experience of taking medicines. Medicines optimisation is about ensuring that the right patients get the right choice of medicine, at the right time. Optimising a person's medicines is important to ensure a person is taking their medicines as intended and can support the management of long-term conditions, multi-morbidities and polypharmacy. There are 4 main principles to Medicines Optimisation: • 1 - aim to understand the patient’s experience • 2 - evidence based choice of medicines

• 3 - ensure medicines use is as safe as possible • 4 - make medicine optimisation part of routine practice 1. Aim to understand the patient’s experience The aim is to ensure all patients are more engaged and understand more about their medicines and are able to make choices, including choices about prevention and healthy living. Patients’ beliefs and preferences about medicines are understood to enable a shared decision about treatment. Patients are able to take/use their medicines as agreed. Patients feel confident enough to share openly their experiences of taking or not taking medicines, their views about what medicines mean to them, and how medicines impact on their daily life. 2. Evidence based choice of medicines This principle ensures that the most appropriate choice of clinically and cost effective medicines are made that can best meet the needs of the patient. The aim is to achieve optimal patient outcomes are obtained by choosing a medicine using best evidence (E.G: NICE guidance) It is important that treatments of limited clinical value are not used and medicines no longer required are discontinued. 3. Ensure medicines use is as safe as possible The safe use of medicines is the responsibility of all healthcare professionals and organisations and should be discussed with patients and/ or their carers. Medicines safety covers all aspects of medicines usage, including unwanted adverse effects, interactions, safe processes and systems, and effective communication between professionals.


CPD 96: MEDICINES OPTIMISATION IN CARE HOMES

This principle aims to ensure incidents of avoidable harm from medicines are reduced, that patients have more confidence in taking their medicines and feel able to ask healthcare professionals when they have a query or a concern with their medicines. Ensuring safe use of medicines means patients remain well and there is a reduction in admissions and readmissions hospitals related to medicines usage. 4. Make medicine optimisation part of routine practice This can be achieved by health professionals routinely discussing with each other and with patients and/or their carers how to get the best outcomes from medicines throughout the patient’s care. By making it routing practice patients feel comfortable to discuss and review their medicines with anyone involved in their care and they receive consistent messages about their medicines because the healthcare team liaise effectively. Problems with medicine use in Care Homes Age-related physiological changes that affect drug handling, polypharmacy and multiple morbidities increase the risk of adverse drug reactions in patients, and make prescribing more challenging. Care home residents are more susceptible to ADRs due to pharmacokinetic (“what the body does to the drug”) and

pharmacodynamic (“what the drug does to the body”) differences when compared to younger patients. Pharmacokinetics involves the study of drug absorption, distributions, metabolism and excretion. Pharmacodynamics involves the study of the response of the body to the drug, the relationship between drug concentration at the site of action and any resulting therapeutic or adverse effects. Pharmacokinetic and Pharmacodynamic factors affecting medicines optimisation in the elderly 1) Body composition changes – affects drug distribution. Increased adipose tissue in elderly patients leads to an increased volume of distribution, half-life and duration of action of fat soluble drugs. E.G.: Diazepam. A reduction in body water results in a decreased volume of distribution, increasing serum levels of water soluble drugs – risk of toxicity. E.G: Theophyline 2) Reduction of first pass metabolism – This the main route of elimination for many drugs. When first pass metabolism is reduced due to age, or when the hepatic blood flow is reduced, there is a reduction of drug delivery to the liver, a reduction in metabolism, leading to increased T1/2, increasing peak concentrations and bioavailability. 3) Renal function decreased – resulting in reduced clearance of drugs, increasing

T1/2 and increasing serum levels – accumulation and toxicity if doses aren’t adjusted. 4) Acute Illness – can reduced drug elimination, affect renal function and absorption 5) Increased sensitivity to particular medicines – due to changes in receptor sensitivity, alteration in blood-brain barrier shield, increasing CNS sensitivity, and damage to cellular functions. Medication errors associated with medicines in nursing homes include unnecessary medicine being prescribed, the wrong dose or strength being prescribed, and not prescribing a medicine that should have been prescribed. Administration errors with medicines can include patients being given the wrong medicine or dose, or were not given a medicine at all. Many factors can contribute to medication errors, and can be patient-related or organisation related. Patient-related factors: • Confusion and lack of awareness about medicines • Patients medical conditions E.g. Dementia • Patients physical condition making it difficult to administer medicines • Swallowing difficulties


CPD 96: MEDICINES OPTIMISATION IN CARE HOMES Organisation-related factors • Problems accessing the clinical record • Inadequate staff experience or education • Staff interruptions and distractions • Inaccurate documentation • Inadequate communication between healthcare professionals – GPs, Pharmacists, Nurses Medication and Falls Elderly patients in care homes are three times more likely to fall than those living in their own homes. Causes of fall can be due to many different reasons, but one important factor is medication and polypharmacy. Medications that act on the central nervous system and the cardiovascular system have the highest risk of causing falls. Taking a psychotropic medicine approximately doubles the risk of falling, and there is evidence that stopping these medicines can reduce falls. Antidepressants and antipsychotics can also cause orthostatic hypotension. Any medication that lowers blood pressure or slows the heart rate can cause falls. Medication review can play a vital role in falls prevention. If modification or withdrawal of the causative medication is not possible, close monitoring is required.

excretion and altered neurophysiology all affect the pharmacokinetics and pharmacodynamics. The common adverse effects of psychotropic medications include:

divided into first-generation and second generation. First-generation antipsychotics

• Benzodiazepines

• Increased risk of falls and skeletal fractures, particularly when given in combination with other medications

• Antidepressants – sedation, hypotension

• Sedative and extrapyramidal effects

First-generation antipsychotic medication act predominantly by blocking dopamine D2 receptors in the brain. They are not selective for any of the four dopamine pathways and so they can cause a range of side effects, particularly extrapyramidal symptoms. The phenothiazine derivatives are divided into 3 main groups:

• Antidiabetics – hypoglycaemic attacks

Extrapyramidal symptoms include:

Group 1:

• Analgesics – sedation

• Parkinsonian symptoms – including tremor

This group is characterised by pronounced sedative effects and moderate anti-muscarinic and extra-pyramidal side effects. E.g. Chlorpromazine, levomepromazine, promethazine

Medicines Associated with an increased risk of falls

• Antihistamines – Piriton, valoid, Phenergan Other medicines that do not necessarily increase risk of falls, but do increase the risk of serious consequences of a fall include long term steroid use – causes osteoporosis . Psychotropic Medication Psychotropic medications are commonly prescribed for elderly pateints to manage behaviour and psychiatric symptoms. Elderly patients are more susceptible to adverse effects and need to be monitored closely. Age related changes such as altered absorption, altered distribution, changed hepatic metabolism, reduced renal

• Orthostatic hypotension

• Dystonia – abnormal face and body movements • Akathisia – restlessness – can resemble exacerbation of the condition being treated • Tardive dyskinesia- rhythmic, involuntary movements of tongue, face and jaw Psychotropic medications include anxiolytics, hypnotics, antipsychotics and benzodiazepines. Antipsychotics are commonly prescribed for patients in care homes, for a variety of indications including schizophrenia, bipolar affective disorder and other psychiatric conditions. Antipsychotics are

Group 2: This group is characterised by moderate sedative effects but fewer extrapyramidal symptoms than group 1 or 3. E.g. Pericyazine Group 3: This group is characterised by fewer sedative and anti-muscarinic effects but more pronounced extrapyramidal side effects than group 1 or 2. E.g. Fluphenazine, prochlorperazine, perphenazine


CPD 96: MEDICINES OPTIMISATION IN CARE HOMES Tool to Alert doctors to Right Treatment. These tools are used by pharmacists and prescribers with the aim to improve the appropriateness of medication and prevent adverse drug reactions. Using this tool it is recommended to stop any drug prescribed without an evidence-based clinical indication, any drug prescribed beyond the recommended duration and any duplicate drug class prescription. Medication review for an older patient can be quite complex, requiring a clear understanding of the therapeutic aims, and the benefits and risks associated with their medication. As patients get older preventative treatments become less meaningful and prescribers need to discuss scaling back or discontinuing some medicines. Checklist to aid prescribing in an elderly patient • Is there a need for pharmacotherapy in this patient? • Is this the optimal medicine for the specific clinical diagnosis in this patient? Second-generation antipsychotic medications act on a range of receptors in comparison to first-generation antipsychotics, and have more distinct clinical profiles. E.g. Olanzapine, risperidone, quetiapine.

patients it is important to choose a short acting benzodiazepine, with low lipid solubility and absence of active metabolite. Benzodiazepines should only be prescribed for short term use of four – six weeks. E.g. alprazolam, lorazepam.

• Will the medicine introduce unnecessary duplication with existing medicines in this patient?

When prescribing for elderly patients the risks and benefits should be considered. In elderly patients with dementia, uses of these drugs are associated with a small increased risk of stroke or transient ischaemic attack. It is recommended that antipsychotics should not be used in elderly patients to treat mild to moderate psychotic symptoms. Initial doses should be reduced to half the adult dose or less, and treatment should be reviewed regularly. Patients receiving antipsychotics should be reviewed at least every 12 weeks by their doctor. It is important to ensure care is compliant with current best practice and that alternatives have been considered.

Polypharmacy and Medication Review

• Is the duration of therapy acceptable?

Most care home patients have multiple and complex conditions and take a variety of different medications. It’s important that medicines are reviewed regularly to ensure that they remain safe and effective. Polypharmacy has been defined as the concurrent use of multiple medicines for one patient. The “average” patient in a nursing home has six diagnoses and takes eight medicines per day. Polypharmacy increases the risk of ADRs in older patient. With each additional medicine comes an increased risk of errors in prescribing, monitoring, dispensing, ADRs, medicinesrelated admissions, impaired medicines compliance and compromised quality of life. NICE recommends that medication reviews should be carried out at a frequency tailored for each individual patient, but should be done at least every year. More frequent review can be required for patients newly diagnosed with a new long term condition, patients who have recently been transferred from a different care home or hospital setting, and patients receiving medication that requires frequent monitoring. Many checklists and tools have been developed to help identity inappropriate prescribing including the STOPP and START criteria. STOPP is a Screening Tool for Older Person’s Prescriptions, and START is a Screening

• Is the medicine likely to interact with existing medication?

Benzodiazepines are commonly prescribed in care homes, with most patients considered chronic users, prescribed for more than 90 days. Benzodiazepines are soluble drugs and in elderly patients the half-life is increased leading to accumulation in the bloodstream. They undergo first pass metabolism, and a reduced hepatic function in elderly patients results in an increased half-life and increasing amount of drug in the blood. Elderly patients also have increased sensitivity to the effects of benzodiazepines. E.g: Excessive sedation. When choosing an appropriate benzodiazepine for elderly

• Is the dosage correct? Is the formulation suitable?

• Is the medicine likely to affect, or be affected by, concurrent disease? Are the directions for use correct and feasible for this patient? Role of the Pharmacist Pharmacists should aim to work more closely with their care homes to improve both the safety and effectiveness of medicines and residents quality of life. Pharmacists should stress to care homes the added value they can bring in terms of reducing medicines supply, medicines waste and in helping nurses and other staff improve their own medicines knowledge. Pharmacists should ensure medication reviews are carried out on a regular basis, and priority given where to antipsychotic medication use prescribed for longer than 12 week, symptoms of sedation and extrapyramidal side effects and where patients display behavioural and psychological symptoms of dementia despite treatment. Robust repeat prescription services and dispensing and regular medication review are areas where pharmacists can work with other healthcare professionals to reduce medication waste.


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Available in packs of 12 or 24. Always read the leaflet. *Sponsors of RTE’s “You should really see a doctor.” Season 3, November - December 2017

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Reminder of Precautions to avoid Photosensitivity Reactions with Fastum Gel (ketoprofen gel) A. Menarini Pharmaceuticals Ireland Ltd. wish to remind healthcare professionals of the necessary precautions to avoid the risk of photosensitivity reactions with Fastum Gel. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) undertook a safety review of topical ketoprofencontaining medicines in 2010 and recommended that doctors should strictly follow the contraindications when prescribing topical ketoprofen. CHMP also recommended that doctors and pharmacists should inform patients on how to use these medicines appropriately to prevent the occurrence of serious skin photosensitivity reactions. A series of risk minimisation measures for Fastum Gel was agreed with the Health Products Regulatory Authority. The Summary of Product Characteristics and the Patient Information Leaflet were updated accordingly and may be found on www.medicines.ie and www.hpra.ie. Patients should be reminded to wash their hands thoroughly after application of the product and to protect treated areas from sunlight by wearing clothing. They should avoid exposing the treated areas to sunlight, even if cloudy, or UVA from sunbeds or solarium during use and for 2 weeks after discontinuation. In addition they should be advised to avoid using Fastum Gel under occlusive bandages and to discontinue Fastum Gel immediately and contact their doctor should any skin reaction develop, including cutaneous reactions after co-application of octocrylene-containing products. A copy of the patient educational leaflet is available from A. Menarini on 01 284 6744 or 1800 283045 or is available at www.hpra.ie A. Menarini would like to remind healthcare professionals that any suspected adverse reactions associated with the use of Fastum Gel should be reported to the Health Products Regulatory Authority at www.hpra.ie or by calling 01 676 4971. Adverse reactions can also be reported to A. Menarini’s Pharmacovigilance Department on 01 284 6744.


News Boots reveals strong growth in sales at Irish outlets Walgreens Boots Alliance, the parent company of pharmaceutical retailer Boots, said that, excluding the UK, comparable sales for its International Retail Pharmacy units rose by 1.1%, driven by good growth in Ireland. The group released its trading update for the fiscal year and fourth quarter that ended August 31, 2018, which revealed that comparable pharmacy sales decreased by 3.4% on a constant currency basis, primarily due to lower prescription volume and a decline in UK pharmacy funding. Overall, the group fell short of analysts' estimates for quarterly revenue as sales of beauty products and prescription drugs fell at its Boots chain, indicating some early impacts from Brexit. The company achieved an overall sales increase by 11.3% to $131.5 billion (¤113.7 billion). Internationally, its Retail Pharmacy division achieved fourth quarter sales of $2.9 billion (¤2.5 billion), a decrease of 1.9% from the same period the previous year. Sales decreased 2.7% on a constant currency basis. “We are pleased to have delivered double-digit percentage growth in earnings per share while returning $6.8 billion (¤5.8 billion) to shareholders through share repurchases and dividends in fiscal 2018,” executive vice chairman and CEO Stefano Pessina said.

“The integration of the acquired Rite Aid stores is on track, and our pharmacy market share in the U.S. increased year-over-year on an annual basis. We are making progress on our partnership strategy both in the U.S. and internationally, including our most recent announcements with LabCorp, Kroger, and Alibaba, which will provide additional opportunities for future growth.” The group’s profit derived from its USA Retail Pharmacy unit, which achieved fourth quarter sales of $25.5 billion (¤22 billion). Pharmacy sales accounted for 73.6% of the division’s sales in the quarter. The company has introduced guidance of 7% to 12% estimated growth in the fiscal year 2019 adjusted earnings per share, at constant currency rates, however, this guidance is based on current exchange rates as well as the execution of its $10 billion (¤86 billion) share repurchase programme. The US owner of Boots pharmacies in Ireland rated growth in sales in the Republic as “good” but gave no new details

Stefano Pessina, Executive Vice Chairman and CEO of Walgreens Boots Alliance

about whether it was mulling further expansion to its 86 outlets. Boots chemists are part of the Retail Pharmacy International division of the US stock market-listed Walgreens Boots Alliance giant. Across all three divisions, including Retail Pharmacy USA and Pharmacy Wholesale,

Walgreens posted a 13% hike in earnings per share, as sales rose 10.9% to $33.4bn in the quarter. It said integrating the purchase of Rite Aid stores in the US was “on track”. The shares, which rose 2.5% in the latest session, have risen 8.7% in the past year, valuing the company at $71.7bn (¤62.3bn).

Robot manufacturer launches report on reducing medication errors Dispensing robot manufacturer Omnicell UK & Ireland has launched a report on reducing medication errors in primary care as part of its ongoing patient safety campaign. In its SAFE: Banishing Medication Errors in Primary Care (Safeguarding Against Frontline Errors) report Omnicell argues that technology “helps to dramatically reduce the risk of medication errors”.

Omnicell UK & Ireland managing director Paul O’Hanlon said: “It is imperative that safety measures are put in place to ensure that patients are taking the right dose of the right medicine at the right time.”

to dramatically reduce the risk of medication errors, providing a valuable safety net for staff and patients. Technology also frees up valuable pharmacy time, which can be redirected back into face-toface, over the counter patient care.

It also found that technology “frees up valuable pharmacy time” spent on managing stock and filling in “medicine adherence packaging”, which can instead be spent on face-to-face patient care, it added.

Omnicell UK&I has launched the ‘SAFE: Banishing Medication Errors’ campaign to raise awareness and promote best practice standards of care for the management of medication to help drive change and improve patient safety across healthcare settings. SAFE will focus on how automation can prevent medication errors in secondary care, care homes and community pharmacy.

Community pharmacies can help to prevent medication errors by installing robotic systems that sort and dispense medication and automated systems which accurately fill and check medication adherence packs.

“With ever-increasing pressures on demand, time and resources…the risk of medication errors in primary care is rising,” Omnicell claimed. The campaign, which uses the #BanishMedErrors hashtag, aims to “drive real change and awareness of the role that technology can play in tackling the problem”, the company said.

The SAFE report, authored by a leading pharmaceutical expert, found that within primary care the introduction of technology helps

Omnicel claims that investing in and installing this technology means that experienced staff no longer spend as much time on operational tasks like restocking, stock rotation and filling medication adherence packaging. It also means that pharmacies have the opportunity to focus on

other valuable revenue streams, such as medicine usage reviews and patient group directives. The company said: “While there has been a growth in the use of robotic dispensing systems in hospital pharmacies, the same cannot be said for community pharmacy. However, as smaller and more efficient robots come to market there is now the opportunity to change this. “Evidence exists to show that pharmacy robots can reduce errors while improving the speed and efficiency of the dispensing process. Robots have the potential to handle high volumes of dispensing in community pharmacies or ‘hubs’ and release pharmacy staff to develop and deliver patient-centred services.”

PHARMACYNEWSIRELAND.COM | 45


Product Launch Innovative skincare product for newborn babies launched in Dublin A new research programme has used non-invasive technology to grow the skin of a newborn baby in a laboratory, leading to the launch of a new series of skincare products. The new products were recently launched by Mustela at the Westbury Hotel in Dublin. A baby’s skin is a protective covering against the outside world. As skin provides protection and aids sensory development, it needs specific care and your full attention from the time the baby is born. In order to give a baby’s skin the care it needs each day, parents need to be able to recognise the baby’s skin type, fully understand the needs and use the right products for that skin type. The new research from Mustela has identified that a baby’s skin is different to adult skin. It is very fragile from birth until the age of

two, as the skin barrier undergoes a maturation process. This makes babies more sensitive to external aggressions. In the research programme (E.V.E.I.L.S), a non-invasive technology has been used, which succeeded, for the first time – in growing the skin of newborn babies in a laboratory, giving the opportunity to explore it at the cellular level. This identified that baby skin has an immature cell barrier, lacks hydration and has fragile cell reserves. This innovative research led to the discovery of four baby skin types, and Mustela have created dedicated ranges with

active ingredients for all 4 types: Normal, Dry, Eczema-Prone and Very Sensitive. How do we diagnose a baby’s skin type? Well Mustela has created a simple and informative online portal to guide mums in their moment of need. This unique portal encompasses a ‘how to diagnose your baby’s skin quiz’, that determines the baby’s skin criteria and allows the mother to discover which Mustela products are best suited for their baby's skin. This innovative venture is aimed to educate, and help mums successfully identify their baby's skin type by breaking down their

baby’s skin into four categories; Normal, Dry, Eczema-Prone and Very Sensitive which is often a misconception among mums. Parents can finally make an informed decision about the skincare choices for their children with Mustela’s Skin Type Campaign. Mustela has specialised in skincare products for babies and their mothers for more than 60 years. Available globally, Mustela ranges are designed to make the skincare routine a moment of sharing, pleasure and emotion that contributes to the well-being and development of the baby and child, and the fulfilment of the new or expecting mother.

Sue Egan, Suzanne Byrne, Tina Buckley, Marie Therese Burke, Tracey Carey and Alex Wiseman from Graham Anthony Distribution

Jamie Heaslip, former Ireland Rugby Captain, being interviewed about Mustela by Xpose Presenter Cassie Stokes

Graham Quinn, founder of Graham Anthony Distribution, addressing the audience with Tina Buckley, Sales & Marketing Manager of Graham Anthony Distribution

Marie Therese Burke, Head Trainer of Graham Anthony Distribution presenting to the audience

46 | PHARMACYNEWSIRELAND.COM


New from The Experts in Omega-3 nutritional supplements MorEPA Move is Minami’s combination of high concentrated 90% Omega -3 with Curcumin, Vitamin C and Copper in a premium formula for flexible movement. Key Ingredients & Benefits  90% Omega-3 contributes to normal heart, vision and brain functions  Curcumin contributes to the flexibility of the joints and the maintenance of strong bones  Vitamin C contributes to the normal collagen formation and for the normal function of cartilage and bones  Copper contributes to the maintenance of normal connective tissues RRP ¤45.99

VeganDHA VeganDHA provides its Omega-3 nutrition from algae and offers vegans and vegetarians an alternate source of DHA in support of brain and eye health. With unsurpassed purity levels VeganDHA offers a clean, orange flavour with no aftertaste. Key Ingredients & Benefits  DHA contributes to the maintenance of normal brain function and vision  DHA intake while pregnant or breastfeeding supports eye and brain development in the foetus and breastfed infant  Enriched with astaxanthin, a powerful antioxidant RRP ¤36.99

Please contact your Valeo Healthcare Sales Rep for order queries: Munster - Fintan Byrne: 087 647 0764 | South Leinster - Stephen Maloney: 087 699 9344 North Leinster - Julie Webster: 086 462 1723 | Connaught – Eamonn Connolly: 087 238 5648


Feature Advice for pharmacists on responding to changes in women’s contraceptive preferences Government initiatives aimed at promoting safer sex, along with maturing public attitudes towards family planning and women’s reproductive health, are contributing to considerable growth in the contraceptives market. used traditionally to prevent pregnancy, condoms are now a necessity in the effort to reduce the global incidence of sexually transmitted infections (STIs). Growing awareness of the dangers of unprotected sex, in conjunction with government initiatives to promote safer sex, are contributing to the growth of the condom market. From a pharmacist's point of view, condoms are a cash-generative, easily-saleable product that people seeking contraceptive options are very likely to consider. It is also a market that is dominated by brands with an international presence and customer recognition is high. Having said that, the worldwide contraceptives market is expected to experience increased competition over the next decade with a renewed emphasis on longer-acting reversible contraceptives, known as LARCs. Educating oneself about women’s changing preferences outside of the condom market can help business owners to make decisions about which products to stock, both in front-of-shop, and in the dispensary. Expert advice Dr Caitriona Henchion is the Medical Director with the Irish Family Planning Association

According to information released by the United Nations (UN), approximately 64 percent of women aged between 15 and 49 years were using some form of family planning method, whether traditional or modern, in 2015: in 1970 that figure was just 36 percent. From barrier methods, to hormone/hormonefree options, to long-acting reversibles and emergency contraception, any woman who wishes to avoid a pregnancy at any stage during her childbearing years has a number of choices

available to her that can often be obtained, sometimes without a prescription, directly from the local pharmacy. With growth in the condom market alone expected to climb from $7 billion in 2018, to approximately $11 billion by 2023, it is clear that opportunities are available for pharmacy businesses to not only assist patients to plan their families (and in the case of condoms to avoid disease), but to also benefit from these progressive changes. While once

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Dr Caitriona Henchion is the Medical Director with the Irish Family Planning Association (IFPA). Dr Henchion spoke to Irish Pharmacy News about women’s changing contraceptive preferences, and the different options that are available. IPN asks if there is any research to indicate which methods Irish women prefer. “The last piece of research that was done on this was by the Crisis Pregnancy Programme back in 2010, and that study dealt with a very broad range of sexual health issues, and one of them was contraception. We have not had anything new since then to inform us about where we are now. Looking at that study, the uptake rate on LARCs

was relatively low at the time, and we do not know what the rate is now because nobody is actually measuring it. I think new research from the State is long overdue and it would be really good to get more data on this.” Despite the lack of hard evidence, Dr Henchion believes that the rate of LARC uptake is increasing, and women presenting to IFPA clinics appear to be opting more frequently in favour of this type of contraceptive method. IPN asks if the changes in what women are choosing is being driven by women themselves, or by healthcare providers. “I think it is a bit of a mixture, certainly there is much better education among GPs about what is available in terms of LARCs, and even if they are not providing it themselves, they are able to inform women where they are available. A lot of evidence shows that the rate of unintended pregnancies goes down the more that LARCs are used and it could be the case that this is what is driving women’s choices. User error is virtually eliminated, such as pill mistakes or not getting back in time for a prescription, and once the LARC is fitted, you have it for three years, five years, or in some cases for 10 years. It has a very low failure rate. “If a woman wants to have an intrauterine device (IUD) or a contraceptive implant fitted, there is virtually no waiting time and pharmacists, as far as we are a aware, have good stock levels in terms of the most popular LARCs. The newer devices are slightly more difficult to get, so that would suggest that women, and we think it is mostly younger women, are choosing the smaller IUDs, so if that is the case that would be a really positive thing. Most of them have very long shelf-lives, so you are not really running any risk of being left with an


NEW IRISH LICENCED PACK

Nelsons are delighted to announce that Teetha Granules have been granted a new Irish only licence from the HPRA. The new licence number is HOA1149/002/001. You will now receive these new packs automatically when you place an order through Wholefoods Wholesale. Please note you can continue to sell through any existing stock you have on your shelf. To place an order call our sales team on 01-6262315 or your local rep.

Braille reads: teetha teething granules

ish TEETHA GRANULES CARTON 929 1262 v3 0/03/2018

NEW IRISH LICENCE NUMBER HOA1149/002/001

15.5 pt 9 pt 7 pt

®

NEW BARCODE FOR IRISH PACK 5000488109849

7 pt All text

Teething Granules

®

Chamomilla 6c

pt

A HOMEOPATHIC MEDICINAL PRODUCT used within the homeopathic tradition for the symptomatic relief of teething pain and the symptoms associated with teething which are sore and tender gums, flushed cheeks and dribbling.

Teething Granules

Chamomilla 6c

7 pt

Teething Granules

®

Teething Granules Chamomilla 6c

A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of teething pain and the symptoms associated with teething which are sore and tender gums, flushed cheeks and dribbling.

24 ready-dosed sachets

National rules authorisation holder & manufacturer: A Nelson & Co Limited, 5-9 Endeavour Way, Wimbledon, London, SW19 8UH, UK HOA1149/002/001 Nelsons, the ellipse logo, Teetha and the Teetha logo are registered trade marks of A Nelson & Co Limited.

ACTIVE INGREDIENT: Each 300mg granules in a sachet contain: Chamomilla recutita (Chamomilla) 6c Also contains: Lactose PRECAUTIONS Please read the enclosed leaflet before use. • Do not give this medicine to the baby if he/she is allergic to any of the ingredients. • Return any unused medicine to your pharmacist for safe disposal. • Keep all medicines out of reach and sight of children. • Do not use after expiry date shown on carton and sachet. • Do not store above 25°C. Store in the original packaging. DIRECTIONS For full instructions, read the enclosed leaflet before using the granules For oral use. For babies from 3 months old. • Detach one sachet from strip of 4. • The baby should be upright or in a sitting position and the granules given slowly into the front of the baby’s mouth, a little at a time. Ensure the granules fully dissolve in the baby’s mouth. Babies 3-6 months a spoon should be used and half a sachet given at a time. Check all the granules have fully dissolved before giving the remaining half. Babies over 6 months the granules should be poured slowly into the baby’s mouth or a spoon may be used.

from 3 months + only

• Use one sachet every 2 hours for a maximum of 6 doses during any 24 hour period.

NEW DIRECTIONS FOR USE

Do not use more sachets than the label / leaflet tells you to. Consult a doctor or qualified healthcare practitioner if the symptoms worsen, or they persist for more than 7 days or if any side effects occur.

A HOMEOPATHIC MEDICINAL PRODUCT 9 pt

A HOMEOPATHIC MEDICINAL PRODUCT used within the homeopathic tradition for the symptomatic relief of teething pain and the symptoms associated with teething which are sore and tender gums, flushed cheeks and dribbling.

LOT NO:

3001262 Art 4929

EXP:

8 pt

Please note: The front of the new licenced packs and formulation is identical to the old packs. There will be no difference to the consumer. FONTS USED: COLOURS: APPROVAL / COMMENT: Product Title: Irish Teetha Granules carton - PRT2017-011

Proof Approved. Please proceed with manufacture to the above standard.

VAG Rounded Standard VAG Rounded Bold

text 7pt


Feature better off without hormones, because in many cases that is not true. For a lot of women, identifying the concern can help you figure out exactly how best to treat this person.” Dealing with emergencies

unsold device, as they do not expire quickly. Some of the newer devices have a little bit less progesterone which some women find helps with things like acne and bloating because it is a slightly lower dose, but also the frame is smaller so it is easier to fit if somebody has not had a pregnancy before. They also last for five years, are very reliable, and there is some evidence to suggest that there is a big increase in the uptake rates for these kind of products as more and more younger women are seeing the benefits of choosing to use intrauterine devices and implants. “That is a really positive thing because it is widely known that LARCs bring down the rate of unintended pregnancies. There has also been a push in the primary care sector to promote copper coils and we increasingly have women coming in to us to discuss them because they do not want to take hormones, but they still want reliable contraception. It does not necessarily suit everybody, but copper coils are definitely a good option to have available and I know for a fact that we are doing more of them now than we used to.” Advice in the community IPN asked Dr Henchion what pharmacists can do in the community to support women who are choosing a method of contraception.

“From our point of view, pharmacists offer big opportunities in terms of information provision. Now that the emergency contraceptive pill is available without a prescription, it brings pharmacists into contact with women who could maybe benefit from the interaction. If the pharmacist is seeing a woman come in more than once, or perhaps she shares with the pharmacist that she missed a pill, or that she was intending to get contraception but just had not gotten around to it, it is an opportunity for the pharmacist to have a discussion about perhaps thinking about more reliable options, because taking emergency contraception is not the most efficient option in the long term. Having something with more lasting effects avoids the worry and the anxiety about unintended pregnancy. “Pharmacists have the information, they are

knowledgeable, and they have great opportunities to pass that information to women in the community. They can play a very active role in increasing the uptake rate on longer-acting contraceptive options, and consequently decreasing the rate of unintended pregnancies.” IPN asked if women are still taking opting for the contraceptive pill. “It is really difficult to know what the actual numbers are because there are still lots of women using the pill, but there is definitely a move towards more natural, hormonefree options, but sometimes it is about sitting down with the person to discover exactly what their concerns are regarding hormone-based contraceptives. If someone has a concern about using the pill and it turns out to be a completely false concern, we prefer to correct that and give them the right information. You have to be careful about advising all women that they would be

The emergency contraceptive hormone (EHC, also known as the ‘morning after pill’) is available over-the-counter in Ireland. It remains an important and reliable method for avoiding unwanted pregnancy and is indicated for use after the patient has had unprotected sex. There are different types of emergency contraceptives available and newer products come now in a single tablet dose. Dr Hension says: “Emergency hormonal contraception acts by either preventing or delaying ovulation, so if it is very likely that a woman is in the stage of their cycle where she has already ovulated, the only thing that is likely to work is the copper coil. You can never tell for sure - you can make an educated guess - but you will be wrong some of the time. In this instance if a woman chooses to have a copper coil fitted in order to avoid an unintended pregnancy, and if there is a delay in actually getting the coil, it would always be recommended that the pill is given, along with information on where to get the copper coil. They are not mutually exclusive and giving something to the woman on the day she presents is the safest option and it is not going to stop the woman from getting a copper coil fitted a couple of days later.” With this in mind, pharmacists should try to stay informed about the changing landscape when it comes to women’s contraceptive choices so that they are poised to respond, without delay, to benefit not only the patient, but the business also.

Pharmacists have the information, they are knowledgeable, and they have great opportunities to pass that information to women in the community

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www.septanazal.ie

Xylometazoline hydrochloride/ Dexpanthenol

Unblocks the nose and heals.

Next generation nasal spray with dexpanthenol

Septanazal® nasal spray with dexpanthenol not only unblocks the nose, but also heals and protects dry and irritated nasal mucosa. + Acts within 5–10 minutes + Long-lasting ease of breathing + Contains no preservatives Septanazal: The nasal spray solution contains xylometazoline hydrochloride and dexpanthenol. Indicated for adults and children over the age of 6 for reducing swelling of the nasal mucosa in rhinitis and as supportive treatment for healing the mucous membrane lesions, for the relief in vasomotor rhinitis and for the treatment of nasal respiratory obstruction after nasal surgery. Adults and children over 6 years of age: The usual dose of Septanazal for adults and children aged 6 years or over is one spray into each nostril up to 3 times a day. Regarding the duration of treatment in children, a doctor should always be consulted. Precautions: This medicinal product may be used only after a careful assessment of the risks and benefits in cases of: patients being treated with the monoamine oxidase inhibitors (MAOIS) and other drugs which potentially increase blood pressure, increased intraocular pressure, especially narrow-angle glaucoma, serious heart and circulatory diseases (e.g., coronary heart disease, hypertension), phaeochromocytoma, metabolic disorders (e.g., hyperthyroidism), porphyria and prostate hyperplasia. In chronic rhinitis it may be used only under medical supervision owing to the danger of the atrophy of the nasal mucosa. The prolonged use and overdose of decongestant sympathomimetics in particular may lead to reactive hyperaemia of the nasal mucosa. This rebound effect causes narrowing of the airways and, consequently, the patient uses the medicinal product repeatedly until its use becomes permanent. The consequences are chronic swelling (rhinitis medicamentosa) or even atrophy of the nasal mucosa. In less severe cases consideration can be given to discontinuing the use of the sympathomimetic in one nostril initially and, after the symptoms have abated, changing to the other side in order to maintain at least part of the nasal respiration. Direct contact of the medicinal product with the eyes should be avoided. In case of misuse or use of excessive amounts of the spray, the absorption of xylometazoline can cause systemic adverse effects, particularly in children (cardiovascular and neurological adverse effects) (see sections 4.8 and 4.9). Concomitant use of the product with medicinal products for local or systemic treatment of the flu and sympathomimetics contained in cough-and-cold medicines (e.g.: pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) is not recommended in order to avoid an increased risk of possible cardiovascular and neurological adverse effects (see section 4.5). Contraindications: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the SPC, dry inflammation of the nasal mucosa, history of transsphenoidal hypophysectomy or other surgical interventions which expose dura mater. Septanazal for adults is contraindicated in children under 6 years of age. Fertility, pregnancy and lactation: Septanazal should not be used during pregnancy, as there is not sufficient data available concerning the use of xylometazoline hydrochloride by pregnant women. Septanazal should not be used during the lactation period, since it is not known whether xylometazoline hydrochloride is excreted in the breast milk. There is no data on the influence of Septanazal on fertility. Adverse reactions: Uncommon: hypersensitivity. Rare: palpitations, tachycardia, hypertension. Very rare: restlessness, insomnia, fatigue, headache, hallucinations, rebound congestion, nosebleed, convulsions. Not known: burning and dryness of nasal mucosa, sneezing. Shelf life: 2 years. Legal category: Medicinal product not subject to medical prescription. Marketing authorisation number: PA1347/058/002. Marketing authorisation holder: Krka, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. http://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA1347-058-002_19012017142039.pdf Date of Preparation: October 2017. Additional information is available on request from Krka Pharma Dublin Ltd. Unit 4A, Leopardstown Business Centre, Ballyogan Road, Leopardstown, Dublin 18. D18 KX88. Reference number: 02-02-2018. * Passàli D, Salerni L, Passàli GC et al. Nasal decongestants in the treatment of chronic nasal obstruction: efficacy and safety of use. Expert Opinion on Drug Safety 2006; 5(6): 783–90.

1/2018, Ireland, 63-2018, RB/MB.

NEW


Advertorial Management Checklist for 2019- Optimising your pharmacy for maximum profitability BY SIMON EAMES, CUSTOMER SUCCESS MANAGER, REAL WORLD ANALYTICS Your pharmacy has a wealth of data – in the dispensary you have data about dispensing volumes and values, fee structures, patient visits and practice trends, medicine usage; your Epos system has data concerning sales values, units sold, margins, stockholding, discounts and so on. The question is, how well are you able to see this data and to use it effectively? Time may be money, as the saying goes, but the effective analysis and presentation of data is the pathway to maximising your profitability, saving you time and money by doing away with the need to spend hours creating spreadsheets. The power of data science combined with practical, visual and businessdriven reporting will enable you to release dormant potential in your business. So, what are the key areas you need to be looking at, and why? Dispensary Financials Knowing the basics of what is happening in your business is a cornerstone to survival, success and growth. Are item dispensings, patient counts, revenues and margins up or down on last year? Which stores are growing, and which are not performing? This is basic data that you need to keep your business plan on track. Claim and Cash Management Managing your claims and keeping a hand on compliance should be a top priority if you are looking to plug the holes through which profits are leaking out of your business. It is all too easy to miss claiming a High Tech patient care fee or to overdispense a patient’s allowance of test strips. Typically, we find that the average store could be losing anything up to ¤500 each month on their bottom line across these two areas alone. Are you able to monitor exceptions to conditions laid down by the PCRS on test strip allowances, Prolia, Victoza, NOACs and other drugs with special conditions so

that you can minimise payment exceptions on these medicines? Loans and future-dated dispensings have cash-flow implications for your business – can you see your loans by age to help you get on top of loan management, and do you know how much medication has been dispensed under forward-dated scripts? Dispensary Products and Stockholding Identifying your preferred dispensing lines from all the available options and then tracking and managing compliance by store and active ingredient is a powerful tool to add points to your margin. Those few pharmacies who are running live stock in the dispensary are seeing the advantages, understanding stock values and weeks cover enables you to reduce overstocks, manage your working capital efficiently and replenish stocks correctly. Dead stock is a dead weight in your business – identifying it is the first step towards solving the problem. Customers who are able to transfer stock in an ethically correct way have reported savings in excess of 50% in write-offs of out-ofdate stock, and this can be achieved even without a live stock model. Whatever your stock model, you need to know what you are dispensing and in what quantities so that you can manage your buying process in the most cost and time-effective way. Dispensary Patients Patients are the lifeblood of your business – it’s good to know not only whether your patient count is up or down, but which of your patients are the most valuable to you and which ones are overdue according to their normal visit cycle. Sure, you need to look after all of your patients but from a patient care point of view and a business perspective it

52 | PHARMACYNEWSIRELAND.COM

makes sense to be aware of the ones who are most important to you. The role of pharmacies in delivering patient services is a hot topic and you should be able to not just offer services but also to easily access your history by store, by service and by patient if you are to maximise opportunities on patient retention and loyalty. Retail Financials There is ongoing market recovery, but the retail landscape is very different now, and the dispensary is under more financial pressure than ever before. Your front of shop can help relieve some of those pressures. You need to be tracking sales, margin and stock levels in each of your stores and departments so that you can maximise your retail opportunities and minimise risks. Retail Stockholding & Product Mix Buying decisions need to be data-driven and based on historical sales and margins as well as market trends, so that you are buying into opportunities and identifying and clearing slow-moving and dead stock. Easy-to-understand reporting on space planning will help you to allocate your retail space by department so that get the most out of each metre of retail shelf space. While range analysis tools will allow you to see which products are driving sales and margins and which are the ones you can really do without. One of the easiest ways to boost your retail turnover is to identify your key year round turnover drivers and make sure that they are never out of stock but also never overstocked. You also need to be aware of seasonal trends – how many anti-allergy medicines did you sell in the first month of spring last year, and are you set up to do the same this year? November and December should account for about a quarter of your annual retail sales – how are you going to make that happen at the best

possible margin and without facing a mountain of unsold stock in January? Running live stock in your front of shop is an easier proposition than in the dispensary and is often the best place to start if you want to get a handle on stock management. Noone likes markdowns, but they are a necessary part of the process if you are to learn from your mistakes and make space for new product offerings. Replenishing stock to manageable levels using live stock and sales data allows you to optimise your stockholding and prevents over-buying, reducing markdowns in the process. Sounds overwhelming? Getting there is a process. While it is important in even a small business, it is vital in larger or expanding groups to achieve and maintain central awareness and control of key performance indicators, and the factors that affect them. All of this data is already in your business, but if you can’t see it you can’t use it. If knowledge is power, and properly analysed and clearly presented data is knowledge in today’s business environment it is knowledge that you can’t do without.

The effective analysis and presentation of data is the pathway to maximising your profitability


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Feature D Day for low levels of vital vitamin, experts warn Vitamin D deficiency hits one in four adults, but even babies are at risk, medical experts warn. As winter sets in pharmacists across the country are preparing to help people tackle Vitamin D shorfalls. Often, customers ask what is Vitamin D and why do we need this fat-soluble vitamin that can be gained from sunlight and 90 per cent of the time? “Vitamin D is a collective term used to describe all sterols that demonstrate the biological activity of cholecalciferol, e.g. Vitamin D2 (ergocalciferol)/ Vitamin D3 (cholecalciferol),” explained Mr O’Driscoll. “D3 is the most favourable form of Vitamin D as this is the natural, most potent form that the body makes from sunlight.” Vitamin D is essential for bone metabolism and Is thought to have beneficial health effects for muscle strength and non-skeletal health.

Professor Rose-Anne Kenny, who carried out a study of ageing

Studies reveal one in four people over 50 are deficient in vitamin D during the winter months.

with supplementation,” warned Principal investigator, professor Rose-Anne Kenny.

“Between October and March there is an insufficient quantity of sunlight to allow adequate production of Vitamin D,” Denis O’Driscoll, (Denis) Superintendent Pharmacist at Lloyds Pharmacy told Irish Pharmacy News.

“This has significant policy and practice implications for Government and health services.”

And leading studies show clear variations in vitamin D deficiency across the country, with the north and west having the highest levels.

“Given that vitamin D can be treated easily with supplementation, this has significant policy and practice implications for Government and health services,” said professor Kenny.

But wherever you are, the lack of this important vitamin is a concern. “Sun rays during winter are the incorrect quality for production and any stores that our body may have are lost quite rapidly,” said Mr O’Driscoll. “Some of those most at risk of deficiency include individuals with darker skin, and pregnant women.” These concerns are backed by a recent study from The Irish Longitudinal Study on Ageing (Tilda) at Trinity College Dublin reveals “The high rates of deficiency seen in the older adult population are of concern given that vitamin D deficiency can be treated easily

Health professionals including pharmacists are being urged to help people understand the risks.

Mr O’Driscoll agreed: “Vitamin D plays a pivotal part in bone health due to its role in calcium regulation. One of the conditions that adequate intake can prevent is osteoporosis – affecting approximately 300,000 people in Ireland. One in four men and one in two women over 50 years of age are likely to be affected. It is worthwhile to note that cutaneous synthesis of Vitamin D also decreases with age.” Severe vitamin D deficiency causes rickets in children and osteomalacia, or softening of the bones, in adults. It may also increase the risk of many other chronic non-bone related diseases.

54 | PHARMACYNEWSIRELAND.COM

However, even during summer, when the body normally produces vitamin D, five per cent of adults were deficient, the Trinity research revealed. Despite the benefits, the TCD study found only 8.5 per cent of those surveyed were found to be supplementing their diet with vitamin D. Lead author of the study and Research Fellow at TILDA, Dr Eamon Laird, said: “This is the largest representative study of the vitamin D status of older adults ever conducted in Ireland and is also one of largest in the world. There are striking differences in the

prevalence of deficiency across different physical and lifestyle factors such as obesity, smoking and physical inactivity, all of which are modifiable risk factors.” Meanwhile, there is evidence showing Vitamin D may have other health benefits including reducing the risk of bowel cancer and most recently breast cancer. Dietary sources include oily fish (e.g. salmon/tuna), egg yolks or fortified foods including milk/ cereal. (D2 would be a preferred supplement for vegans as D3 is sourced from animals). However, these foods are often not regularly consumed and often don’t contain a sufficient supply There is some voluntary fortification food products, and there have been calls for this program to expand to include a wider range of foods. And Supporting HSE Guidelines the Superintendent Pharmacist said: “all infants under one year of age, be they breastfed, formula fed or eating solid foods should be supplemented with at least 5μg (200IU) daily.” Vitamin D intake is recommended at 10–20 micrograms daily. However, some studies suggest that a higher daily intake of between 38μg and 75μg is needed to maintain optimal blood levels There is some voluntary fortification of food products, and there have been calls for a wider range of foods to be fortified with the vitamin.

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News Smart tools for medication management: Irish med tech company on upward trajectory HealthBeacon, which is an Irish company that specialises in the development of smart tools for medication management, recently celebrated the opening of a new production facility. Minister of State for Mental Health and Older People, Jim Daly TD, attended the event, which marked the official opening of the newly expanded Irish headquarters in Dublin 12. HealthBeacon currently serves thousands of patients across 10 markets in Canada, Europe, the Middle East and South America. and ongoing continued investment here in Ireland, our global HQ. The company has entered multiple new markets this year and received FDA clearance allowing us to enter the US market, with the world’s only Smart Sharps Adherence Platform. Looking forward, we are committed to continuing contributing to Ireland’s reputation as a global leader offering innovative best in class healthcare solutions.” Jim Daly T.D., Minister of State for Mental Health and Older People, Jim Joyce, HealthBeacon CEO, Kieran Daly, HealthBeacon CTO, Terence O'Rourke, Chairman Enterprise Ireland and Orla O'Gorman, Head of Equity Listing, Euronext Founded in 2014, this has been the company’s busiest year with the launch of its new ‘Smart Sharps’ bin, which is an injectable medication management system that monitors patients digitally, helping them to keep them adherent to their prescription. The data collected is also used to drive more effective clinical interventions. Colm Gildea is the commercial country manager for HealthBeacon. Speaking to Irish Pharmacy News, Gildea said: “The stand-alone device is bringing MedTech into the ‘heart of the home’ helping to address one of the biggest unmet needs within the health arena, tracking patient’s real

time usage and supporting chronic medicine schedules. This system has been clinically reviewed, validated by the pharmaceutical industry, and has been integrated into patient care programs throughout North America and Europe, delivering valuable data to both the patient and their clinical teams. Over the past four years this innovative company has experienced comprehensive market penetration within Ireland, witnessing in excess of 100% market growth, while also doubling its staff over the past 18 months.” Jim Joyce is the CEO of HealthBeacon. “2018 has been a fast track year for HealthBeacon and today reflects our successes

Speaking at the event, Chairman of Enterprise Terence O’Rourke said: “I am delighted to be at the opening of the HealthBeacon expanded production facility to support the company’s growth activities. Working closely with Enterprise Ireland since 2014,

HealthBeacon is designing and developing digital tools that impact positively on the lives of patients worldwide. “The thriving Irish Medtech sector continues its story of success and the development of innovative products such as the Smart Sharp Bin contribute significantly to Ireland’s reputation as a global leader in healthcare solutions. Our aim at Enterprise Ireland is to help businesses with global ambition to build scale and expand reach, and we will continue to work with HealthBeacon as it delivers medical solutions through innovation, underpinning the company’s continued growth in world markets.”

Kieran Daly, HealthBeacon CTO, Terence O'Rourke, Chairman Enterprise Ireland, Orla O'Gorman, Head of Equity Listing, Euronext, Jim Daly T.D. and Minister of State for Mental Health and Older People, Jim Joyce, HealthBeacon CEO

Four in five are disposing of medication inappropriately, new survey reveals A survey carried out by Initial Medical, which is one of the world’s largest business services companies, has revealed that over 78 percent of people dump their unused and out-of-date medication in the bin, with only 13 percent returning old meds to the pharmacy. Seven out of ten were not aware that incorrectly disposing medication greatly increased the risk of water contamination, putting plant and animal life in danger. Dr Colm Moore, who is the Area Technical Manager for Initial said: “It is always best practice to ensure that you bring any unused and expired medication back to your pharmacy, so that it can be disposed of in an environmentally responsible manner. Many people are unaware of the risk of environmental contamination that comes with disposing of old medicines through normal household waste disposal or by flushing them down the toilet.” Commenting further, Dr Moore said: “Initial strongly urges the HSE to take action to raise awareness of this issue and educate the

public that bringing their expired medicines to the pharmacy is an option.”

by Initial Medical, with 300 respondents. Some of the notable results include:

Several DUMP (Dispose of Unused Medicines Properly) projects were successfully completed in the Southern HSE regions and Initial Medical is offering a pharmaceutical waste recovery service tailored specifically for retail, HSE and hospital pharmacies throughout Ireland to ensure the safe disposal of pharmaceutical waste in compliance with all national and EU regulations.

- 78.6% of those surveyed dispose of their old medication by throwing them in the bin.

This survey was carried out

56 | PHARMACYNEWSIRELAND.COM

- 51.8% of those surveyed would advise a friend or family member to throw out expired medication, while 48.2% of those surveyed would not.

- 13.6% of those surveyed dispose of their old medication by bringing them back to the pharmacy.

- 61.4% of those surveyed were unaware that bringing expired medication to the pharmacy to dispose of it was an option, while the remaining 38.6% were aware of this.

- 40% of those surveyed sometimes consume old medications if they went out of date in the last year, while 57.7% never consume old medications.

- 68.2% of those surveyed were unaware of the dangers to the environment associated with inappropriately disposing of medication, while only 31.8% of people surveyed were aware of the risks.


Grasping every opportunity, not gasping for air THE DIFFERENCE IS

Symbicort is licensed for use in patients with asthma and COPD (FEV1 <70% predicted normal (post bronchodilator) and an exacerbation history despite regular bronchodilator therapy. Symbicort is not intended for the initial management of asthma. ABRIDGED PRESCRIBING INFORMATION SYMBICORT® TURBOHALER® 100 micrograms/6 micrograms/ inhalation, inhalation powder. SYMBICORT® TURBOHALER® 200 micrograms/6 micrograms/inhalation, inhalation powder. SYMBICORT® TURBOHALER® 400 micrograms/12 micrograms/inhalation, inhalation powder. (budesonide/formoterol fumarate dihydrate). Consult Summary of Product Characteristics (SmPC) before prescribing. Indication: Indicated in adults, adolescents aged 12 years and older and children aged 6 years and older (100/6 only), for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting ß2 adrenoceptor agonist) is appropriate: 1) patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting ß2 adrenoceptor agonists or 2) patients already adequately controlled on both inhaled corticosteroids and long-acting ß2 adrenoceptor agonists. Symbicort 100/6 is not appropriate for patients with severe asthma. Symbicort 200/6 and 400/12 only: Indicated in adults aged 18 years and older for the symptomatic treatment of patients with COPD with FEV1 <70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy. Presentation: Inhalation powder. Symbicort 100/6: Each metered dose contains budesonide 100mcg/inhalation and formoterol fumarate dihydrate 6mcg/inhalation. Symbicort 200/6: Each metered dose contains budesonide 200mcg/inhalation and formoterol fumarate dihydrate 6mcg/inhalation. Symbicort 400/12: Each metered dose contains budesonide 400mcg/inhalation and formoterol fumarate dihydrate 12mcg/inhalation Dosage and administration: Asthma: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Symbicort maintenance therapy: Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times. Adults (18 years and older): 100/6 and 200/6: The recommended dose is 1-2 inhalations twice daily. Some patients may require a maximum of 4 inhalations twice daily. 400/12: 1 inhalation twice daily. Adolescents (12-17 years): 100/6 and 200/6: The recommended dose is 1-2 inhalations twice daily. 400/12: 1 inhalation twice daily. Children 6-11 years (100/6 only): The recommended dose is 2 inhalations twice daily. Children under 6 years: Not recommended. Symbicort 400/12 is not recommended for children under 12 years. Symbicort maintenance and reliever therapy: 100/6 and 200/6 only (not indicated with 400/12 strength) Adults and adolescents (12 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. No more than 6 inhalations should be taken on any single occasion. A total daily dose of more than 8 inhalations is not normally needed, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. Children under 12 years: Not recommended. COPD (200/6): The recommended dose in adults is 2 inhalations twice daily. COPD (400/12): The recommended dose in adults is 1 inhalation twice daily. Elderly: No special dosing requirements required. Patients with hepatic or renal impairment: Increased exposure is expected in patients with severe liver cirrhosis. Contraindications: Hypersensitivity to active substance(s) or excipients. Warnings and precautions: Recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. If treatment is ineffective, or exceeds the highest recommended dose, medical attention must be sought. Sudden and progressive deterioration in control of asthma or COPD is potentially life threatening and patient should undergo urgent medical assessment. Consideration should be given for increased therapy with corticosteroids, e.g. orally, or antibiotic treatment if infection present. Patients should have their rescue inhaler available at all times. Patients should be reminded to take their maintenance dose as prescribed, even when asymptomatic. The reliever inhalations should be taken in response to asthma symptoms but are not intended for regular prophylactic use e.g. before exercise, separate rapid-acting bronchodilator should be considered. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose. Patients should not be initiated on Symbicort during an exacerbation or if they have significantly worsening or acutely deteriorating asthma. Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Symbicort should be discontinued immediately and an alternative therapy instituted if necessary. Systemic effects may occur, particularly at high doses prescribed for long periods e.g. Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Recommended that height of children receiving prolonged treatment is regularly monitored and if growth is slowed, therapy should be re-evaluated and consideration given to referring the patient to a paediatric respiratory specialist. If adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to Symbicort therapy. Patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. HPA axis function should be monitored regularly. Prolonged treatment with high doses of inhaled corticosteroids may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery. Rapid reduction in dose of steroids can induce acute adrenal crisis, symptoms may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, seizures, hypotension and

hypoglycaemia. Treatment with systemic steroids should not be stopped abruptly. Transfer from oral steroid therapy to Symbicort may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema, muscle and joint pain. Specific treatment should be initiated for these conditions. In rare cases, tiredness, headache, nausea and vomiting can occur due to insufficient glucocorticosteroid effect and temporary increase in the dose of oral glucocorticosteroids may be necessary. To minimise risk of oropharyngeal candida infection, patients should rinse mouth with water after inhaling doses. Concomitant treatment with itraconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided. Observe caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders such as ischaemic heart disease, tachyarrhythmias or severe heart failure. Observe caution when treating patients with prolongation of the QTc-interval. Re-evaluate need for Symbicort in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways. Hypokalaemia may occur at high doses of ß2 adrenoceptor agonists. Particular caution recommended in unstable or acute severe asthma. Monitor serum potassium levels. As for all ß2 adrenoceptor agonists, consider additional blood glucose monitoring in diabetic patients. Visual disturbances may be reported with systemic and topical corticosteroid use. If a patient presents with these symptoms, consideration to ophthalmologist referral should be given to evaluate possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy. The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions. 200/6 & 400/12: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. Physicians should remain vigilant as clinical features of such infections overlap with symptoms of COPD exacerbations. Risk factors include current smoking, older age, low BMI and severe COPD. Potential effects on bone density should be considered especially in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis. Drug interactions: Potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors) are likely to increase plasma levels of budesonide and concomitant use should be avoided. If this is not possible the time interval between administration should be as long as possible. Symbicort maintenance and reliever therapy is not recommended in patients using potent CYP3A4 inhibitors. Not to be given together with beta-adrenergic blockers (including eye drops) as can weaken or inhibit the effect of formoterol, unless compelling reasons. Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine) and TCAs can prolong the QTc-interval and increase the risk of ventricular arrhythmias. L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards ß2-sympathomimetics. Concomitant treatment with MAOIs, including agents with similar properties such as furazolidone and procarbazine, may precipitate hypertension reactions. Elevated risk of arrhythmias in patients receiving anaesthesia with halogenated hydrocarbons. Concomitant use of other beta-adrenergic drugs or anticholinergic drugs can have a potentially additive bronchodilating effect. Hypokalaemia may increase the disposition towards arrhythmias in patients taking digitalis glycosides. Hypokalaemia resulting from beta2-agonist therapy may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and diuretics. Pregnancy and lactation: Use only when benefits outweigh potential risks during pregnancy and breastfeeding. Budesonide is excreted in breast milk; at therapeutic doses, no effects on child are anticipated. Not known whether formoterol passes into human breast milk. Undesirable events: Consult SmPC for full list of side effects. Common: Headache, palpitations, tremor, candida infections in the oropharynx, coughing, mild irritation in the throat, hoarseness and pneumonia (in COPD patients using Symbicort 200/6) Uncommon: Tachycardia, muscle cramps, aggression, psychomotor hyperactivity, anxiety, sleep disorders, nausea, dizziness, blurred vision and bruises. Rare: Hypokalaemia, cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles, bronchospasm and immediate and delayed hypersensitivity reactions including exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction. Very rare: Depression and behavioural changes (predominantly in children), angina pectoris, prolongation of QTc-interval, hyperglycaemia, taste disturbances, Cushing’s Syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and variations in blood pressure. Paradoxical bronchospasm may occur in very rare cases. Package Quantities Each Symbicort Turbohaler 100/6 or 200/6 contains 120 inhalations. Each Symbicort Turbohaler 400/12 contains 60 inhalations. Legal category: POM. Marketing authorisation numbers: PA 970/28/1-3 Marketing Authorisation Holder: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK. Further information available on request from The MAH (address above), Freephone – 1800 800 899. SYMBICORT and TURBOHALER are trademarks of the AstraZeneca group of companies. Date of API preparation: 12/2017 API REF: IE-0607 Adverse events should be reported directly to: HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2. Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie. Adverse events should also be reported to AstraZeneca Medical Information on 1800 800 899.

Date of Preparation: January 2018. VEEVA ID: IE-0649


News New flexible pharmacy solution for EU Falsified Medicines Directive (FMD) compliance unveiled TraceLink Inc., a Track and Trace Network for connecting the life sciences supply chain and providing realtime information sharing for better patient outcomes, has announced Smart Rx Manager, a solution that enables pharmacists, hospitals, clinics and dispensing doctors to achieve compliance with the verification and decommissioning requirements of the European Union Falsified Medicines Directive (FMD). verification or decommission request to their national medicines verification systems (NMVS). Upon submission, Smart Rx Manager will immediately receive a status from the NMVS as required under EU FMD. Larger hospital and pharmacy operations can choose to integrate Smart Rx Manager directly into their existing PMR software, based on the specific workflow requirements.

Shabbir Dahod, President and CEO of Tracelink

The requirements of EU FMD dictate that healthcare providers must scan, check and verify a medicine’s authenticity against a national repository before a pack is decommissioned and supplied to a patient. Available as a mobile application or as a solution that can be integrated with exisitng pharmacy systems, Smart Rx Manager requires no additional scanning hardware, making it a flexible

EU FMD solution for hospitals, pharmacies and dispensing doctors, and minimizing disruption in any pharmacy environment. With Smart Rx Manager, pharmacists and doctors can use mobile devices running iOS or Android operating systems to scan serial numbers of any prescription medicine and submit the product code (GTIN/ NTIN), serial number, lot or batch number and expiry date with a

“More than 130,000 community pharmacists, hospitals and dispensing doctors will be affected by the approaching February 2019 EU FMD deadline. With many concerned about the financial and resource intensive burden of implementing EU FMD processes, Smart Rx Manager has been designed to streamline the process of achieving EU FMD compliance, through a light-weight mobile device or integrating into existing pharmacy operations with minimal investment,” said Shabbir Dahod, president and CEO, TraceLink. “Using Smart Rx Manager will enable pharmacists to meet their immediate EU FMD compliance needs, but also connect to TraceLink's network of more than 270,000+ trade partners and take

advantage of new digital solutions for product recalls, patient engagement and personalised medicine.” The application is not dependent on other pharmacy software or hardware and provides full visibility into pharmacy transactions through a configurable dashboard. Smart Rx Manager can also be integrated with pharmacy management software systems and dispensing robot manufacturers to assist with FMD compliance. The product provides a number of features which comply with EU FMD including: • Simple, Out-of-Box Set Up: The application runs on mobile devices (iOS or Android) and can be easily downloaded through the TraceLink website. • Easy-to-Use FMD Compliant Scanner: Any mobile device camera can be used for scanning, eliminating the need for purchasing extra scanning hardware. • Optional Higher Volume Scanner Compatible: Smart Rx Manager can also connect wirelessly with optional Bluetooth scanners.

COPD Support Ireland hosts ‘Let’s Get Moving’ conference COPD Support Ireland, the umbrella body for 20 local COPD support groups, has announced details of its “Let’s Get Moving on COPD” national patient conference for people with COPD – Chronic Obstructive Pulmonary Disease. Perhaps more commonly known as bronchitis or emphysema, COPD is a chronic lung condition whose primary symptoms are breathlessness, persistent cough and regular chest infections. The conference, which takes place in the Royal College of Physicians, Kildare Street, Dublin 2, on Thursday November 15, will focus on improving self-care for people with COPD, and offer contributions from leading experts on the future of COPD treatment. A series of parallel workshops will also take place featuring activities that will help people with COPD to better manage their condition and look after their physical and mental well- being. These will include workshops on singing, art therapy,

coping with breathlessness, benefits and entitlements, guidance for carers and preparing for retirement. Nurses will also provide walkin COPD clinics where people can gain information and seek support on minding their condition, including inhaler technique advice. The conference is supported by unrestricted educational grants from A. Menarini, Air Liquide, Astra Zeneca, Direct Medical, GSK, Home Health Care and Novartis. It’s estimated that there are almost half a million people in Ireland with COPD, however, many do not know they have it. To mark World COPD Day, which takes place on Wednesday

58 | PHARMACYNEWSIRELAND.COM

November 21, COPD Support Ireland is undertaking a number of initiatives to raise awareness of COPD, and provide support for those with the disease, including: • A new booklet, COPD & Me • New and expanded series of community-based exercise programmes being rolled out in 12 counties across the country, including Carlow, Cavan, Clare, Dublin, Galway, Kilkenny, Limerick, Louth, Sligo, Tipperary, Waterford, and Wexford. Check www.copd.ie for details • Public information packs, including posters and leaflets – available by getting in touch with COPD Support Ireland

The community-based exercise programmes are delivered by qualified trainers and designed to support self-care, reduce flare-ups and hospitalisations in people with COPD. A rolling series of 12-week programmes, they will run over the next year and also focus on issues such as smoking cessation, nutrition and inhaler advice. Exercise is a key aspect of treatment for patients with obvious physical health benefits such as increased muscle strength, agility, flexibility and aerobic endurance, not to mention the social and mental health benefits. The programme also helps to slow progression of the disease which will, in turn, lead to fewer GP and hospital visits.


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To place your order please contact your local Pemberton rep or customer services on: Tel: 01-463 2424 Email: cs.pemberton@united-drug.com

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Please consult the Summary of Product Characteristics before prescribing, information about this product can be found at www.medicines.ie Further information is available on request from UCB Pharma Ireland Ltd, United Drug House, Magna Drive, Citywest Road, Dublin 24 MA Numbers:

Zirtek 1 mg/ml oral solution: PA 891/8/3, Zirtek Plus Decongestant 5/120mg Prolonged Release Tablets PA 891/8/1, Zirtek Tablets PA0891/008/005

Product licence holder:

UCB Pharma Limited

Classification:

Zirtek tablets & oral solution: Cetirizine dihydrochloride Zirtek Plus Decongestant prolonged release tablets: Cetirizine dihydrochloride, Pseudoephedrine hydrochloride

Legal Category: OTC

Adverse events should be reported to the Health Products Regulatory Authority at www.hpra.ie or via email to medsafety@hpra.ie Adverse events should also be reported to UCB Pharma Ireland Ltd via email UCBCares.IE@ucb.com

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*Provides significant improvements in quit rates vs patch alone. NiQuitin Clear 14mg Patches. Indication: Stop Smoking aid, Contains nicotine, Requires willpower. always read the leaflet. Legal classification: gSL. Pa 1186/18/5. MAH: Chefaro ireland DaC, Treasury Building, Lower grand Canal Street, Dublin 2, ireland. RRP (ex. vaT): 7ct €25.75, 14ct €46.40 information about the product including adverse reaction, precaution, contra-indication and method of use can be found at: http://www.medicines.ie/medicine/12137/SPC/NiQuitin+CLeaR+14+mg+24+hours+transdermal+patch/ (14 mg). NiQuitin Mini Mint 1.5 mg Lozenges. Stop Smoking aid, Contains nicotine, Requires willpower. always read the leaflet. Legal classification: gSL Pa 1186/18/11 (1.5mg) PL. MAH: Chefaro ireland DaC, Treasury Building, Lower grand Canal Street, Dublin 2, ireland. RRP (ex. vaT) Triple Pack €21.05. information about the product including adverse reaction, precaution, contra-indication and method of use can be found at: http://www.medicines.ie/medicine/14493/SPC/NiQuitin+Mini+1.5mg+mint+lozenges (1.5mg). Date of preparation: 12/09/2018.


News LloydsPharmacy reveals cardiovascular age and skin analyser machines With a sharp change in weather and winter approaching, LloydsPharmacy has launched a new seasonal health and wellness campaign, the ‘Best Version of You’, to educate customers on preparing for winter and staying healthy. part of an overall heart health initiative. With over 10,000 lives lost to heart disease in Ireland every year (Irelands biggest killer disease) this test improves cardiovascular risk monitoring and promotes adherence to treatment and lifestyle changes.

The LloydsPharmacy 'Best Version of You' campaign launched at the Airfield Estate At the launch, trained pharmacists and health and well-being experts provided one-on-one health consultations, highlighting the free services available for patients in LloydsPharmacy nationwide. LloydsPharmacy also officially revealed two new machines exclusively available in LloydsPharmacy: the cardiovascular age machine and skin analyser machine. The new cardiovascular age machine service, which measures vascular age and blood pressure, is available in select stores nationwide. As a non-invasive and simple method, the cardiovascular age machine has shown to be useful as

The new skin analyser machines are currently being piloted in five Dublin stores: Nutgrove Shopping Centre, Leopardstown, Blanchardstown Shopping Centre, Blackrock Shopping Centre, and The Mill Shopping Centre. The skin analyser machines, operated by the LloydsPharmacy skincare specialists, tests skin for hydration, elasticity, sebum, pore, wrinkle, sensitivity, melanin and acne. The test is free and takes just three minutes to complete. The skin analyser test is used to help the skincare specialist develop a tailored skin care regime for customers. Both machines expand the pharmacy’s free health consultation services. As part of the Best Version of You campaign, LloydsPharmacy colleagues in all nationwide stores are on hand to provide expert advice for the whole family to prepare for winter and stay healthy. Trained colleagues can advise on preventing winter ailments, as well as winter medication and

pain management, skin care, heart health, vitamins and supplements and more, should illness occur. In the last year, LloydsPharmacy colleagues have collectively undergone more than 17,000 hours of specialised training in heart health, skincare, seasonal health, flu, chronic disease management and prevention, and more. This year as part of a partnership with Irish Heart foundation, pharmacists received training by IH foundation medical experts and will refer to LloydsPharmacy as Heart health hubs to conduct Blood Pressure, Pulse checks and artrial defibribulation. This year, LloydsPharmacy has expanded its flu vaccination service to 52 stores nationwide, increasing from 32 in 2017. The vaccination will be administered in a private consultation room and takes less than 30 minutes. Blood pressure screening and BMI measurement are also available in stores all year round, free of charge. The LloydsPharmacy ‘Best Version of You’ campaign was launched at Airfield Estate, Dundrum, with nutritional therapist Elsa Jones and wellness expert Sarah Doyle. Media and influencer attendees embarked on an experiential journey which included a culinary lesson, wellness session and private health consultation.

Dervila McGarry, Head of Marketing at LloydsPharmacy, said: “We created this event to demonstrate the high-quality service that LloydsPharmacy provides throughout the winter season. “LloydsPharmacy colleagues have been specially trained to provide customers with personalised winter health and wellness advice and our event at Airfield Estate provided media and influencers with an overview of services and products available across 92 stores nationwide.” Speaking at the launch, Denis O’Driscoll, Superintendent Pharmacist at LloydsPharmacy, said: “The Best Version of You campaign highlights the importance of preparing for winter at a time of year when staying healthy is most demanding. “During winter, harsh weather can weaken our immune systems. Incidences of seasonal illness, and viruses such as flu, rise in winter and can easily spread. Harsh weather can also aggravate our skin and chronic diseases such as asthma. “Understanding the preventative steps to avoid illness is really important. The flu vaccination is available in select LloydsPharmacy stores nationwide. It not only helps to protect against catching the flu, but also ensures the infection isn’t passed on.

First reports of the spread of winter flu Flu season has officially begun with the publication of the first report on the spread of the illness by the HSE’s Health Protection Surveillance Centre. The HPSC report shows that the number of cases of flu being reported by GPs is still low, with only seven cases of “influenza like” symptoms officially reported in the first week of October. However, the risk of an outbreak increases significantly around this time of year prompting a timely reminder of the importance of the flu vaccine. Stocks of this year’s flu vaccine have already been arriving at CarePlus pharmacies around the country, with community pharmacists echoing calls for at-risk groups to get the important inoculation “sooner rather than later”. Influenza, or ‘seasonal flu’, is a highly infectious illness caused by the flu virus affecting the lungs and upper airways, bringing with

it a sudden high temperature and general aches and pains. The symptoms can last for up to a week, and people can lose their appetite, feel nauseous and have a dry cough, and they may need to stay in bed until they’re better. Martin Slattery from CarePlus pharmacy in Headford, County Galway says, “The sooner you get the flu vaccine, the sooner you’re protected. It can take two to three weeks for it to take full effect so I’d urge people who need it to act now. “It’s really important that people in at-risk groups like the over 65s, Diabetes patients, pregnant women and those with chronic illnesses get the jab. Some people qualify for a free dose, and we can advise them on that.

Martin also insists that while a mild reaction can happen, the vaccine is safe, “There can be some mild soreness or redness at the site of the vaccination, and maybe some cold-like symptoms, such as a runny nose, but the vaccine absolutely cannot give you the flu. If you’re in an at risk group, the flu can be a potentially life-threatening illness and people die in this country from it every year.” Meanwhile Asthma Society CEO, Sarah O’Connor, said: “Every effort should be made to avoid contracting the highly contagious flu virus by members of the public, but especially by people with asthma. People with asthma are at a higher risk of the flu leading to complications for them and possible death, if they have a serious asthma attack. We’ve

Asthma Society CEO Sarah O'Connor compiled a list of tips on how to avoid contracting the flu virus, along with a list of what should be done if you get the virus and we are urging everyone with asthma to follow this guidance.”

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Advertorial Pharmacists play a vital role in discouraging sexual risktaking among young people Recent research of over 2,000 Irish 18-24 year olds has found that 6 in 10 have had unprotected sex in the past while 33 percent said they have experienced contraceptive failure during sex.1 The research was carried out by ellaOne, the oral emergency contraception, to understand the level of sexual risk taking among Irish young people and gain an insight into their attitudes to contraception and emergency hormonal contraception (EHC). The research found that over half (57 percent) of women said they have taken the morning after pill in the past, with around 30 percent of these having taken it three times or more. Worryingly, almost 4 in 10 (38 percent) who had taken the morning after pill before said there were other instances after unprotected sex when they could also have taken it but didn’t.1 The reasons for opting not to take it varied from making a conscious decision to ‘risk it and hope it didn’t result in an unplanned pregnancy’ (27%), to being too embarrassed to go in to Pharmacy (20%), while almost half said they felt that they were just ‘overreacting’ (48%). Other reasons included concerns around cost, researching online to self-assess whether they needed to take EHC or not and seeking advice from friends.1 The sense of ‘overreaction’ among young people is concerning according to ellaOne Senior Brand Manager, Emma Marsh, “The volume of responses to our research has given us an extremely robust depiction of Irish young people’s attitudes to sex and contraception. The fact that almost half feel that taking EHC after unprotected sex can be an overreaction is concerning, especially when you look at the incidences of unplanned pregnancy in these circumstances. Without intervention, 55 in every 1,000 women will become pregnant after unprotected sex. With ellaOne, this is reduced to 9 women.”2 “Young people need to understand the importance

We are listening to real women and their lived experiences of seeking the morning after pill and we want to help alleviate the embarrassment many women feel during the purchasing process of safe sex but also need to feel equipped and empowered to make the right choice for them if they find themselves in a situation where their contraception has failed or they haven’t used any. We want to encourage young women to seek advice and reassurance in the pharmacy, and we are investing heavily in campaigns that will drive women into pharmacy”, she said. This month ellaOne launched a new Golden Shield pill and pack as a universal symbol of protection and standard of efficacy in EHC. The new pill will be instantly recognisable to pharmacists and consumers alike with a new easy to swallow3 film-coated, golden tablet. The launch is being supported by a large advertising programme across digital including Google ads and social media, as well as a significant partnership with the leading website for young Irish women, Her.ie. This partnership, which includes the consumer research carried out, also includes informative podcasts, video content, articles and quizzes. Emma Marsh continued, “We are listening to real women and their lived experiences of seeking the morning after pill and we want to help alleviate the embarrassment many women feel during the purchasing process. Through our partnership with Her.ie we are talking to real Irish women, understanding their experiences and creating relevant, informative and de-stigmatising content. By giving women all of

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the facts we want to empower them with the right information so they feel comfortable taking EHC if and when they need it.” She continued, “It is also vital that the experience women have, if and when they go into Pharmacy, is a positive one. The morning after pill is still a spontaneous and hated purchase for most women and a simple and positive experience in Pharmacy means that young people can feel more comfortable accessing emergency contraception and are less likely to risk unplanned pregnancies in the event of future unprotected sex. It also means that if they find themselves giving advice to friends in a similar situation then they may feel more likely to encourage them to go and get EHC.” Good Pharmacy Practice can include: • Asking the right questions and avoiding unnecessary, personal or intrusive questioning • Providing quality advice in a sensitive way, without lecturing • Providing an environment where women feel comfortable and not judged, for requesting emergency contraception. You can help by being matter-of-fact, re-assuring them they have done the right thing and having a warm and positive approach. Your Pharmacy Team should also know that your

aim is to offer women EHC in a reassuring and positive way. For more information on ellaOne and the consultation process visit www.ellaonepharmacists.ie ellaOne® is an oral emergency contraception at preventing pregnancy in the first 24 hours after unprotected sex and should be taken as soon as possible after unprotected sexual intercourse.4 ellaOne is 2.5 times more effective than levonorgestrel and is suitable for the vast majority of women.4 Over 16 million have used it in more than 70 countries around the world. 5 ellaOne® is generally well tolerated with an established safety profile.4 More information can be found at www.ellaonepharmacists.ie References: 1. Research conducted by Empathy through an online survey across 2,107 18-24 year olds. Research was conducted amongst members of Empathy Research’s proprietary research panel and through the Her.ie website. Fieldwork was conducted from 12th May – 2nd June 2018 2. Glasier A et al. Lancet 2010; 375(9714):555-62. 3. HRA data on file: consumer swallowability research 2017 4. ellaOne® Summary of Product Characteristics. 5. Group Sales Data since 2009.


Protect her

IE/ELLA/0053 Date of preparation: October 2018

morning after

NEW ellaOne, the most effective Emergency Hormonal Contraceptive (EHC)1, is changing to a new shield-shaped golden pill and packaging.

shield-shaped pill

Golden shield as a universal symbol of protection and standard of efficacy in EHC Easy to swallow film-coated tablet.2 Visit www.ellaonepharmacists.ie REFERENCES: 1. Glasier A et al. Lancet 2010; 375 (9714): 555-62. 2. HRA data on file: consumer swallowability research 2017

PRODUCT INFORMATION: ellaOne® 30 mg film-coated tablet (ulipristal acetate). Refer to the SmPC for further information. INDICATION: Emergency contraception (EC) within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. DOSAGE: one 30mg tablet taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure. Another tablet should be taken if vomiting occurs within 3 hours of intake. Can be taken at any time during the menstrual cycle. Not recommended for women with severe hepatic impairment. CONTRAINDICATIONS: Hypersensitivity to the active substance or excipients. SPECIAL WARNINGS AND PRECAUTIONS: Occasional use only. Use reliable barrier method after use until next menstrual period. If next menstrual period is delayed >7 days or is abnormal or suggestive symptoms occur then perform pregnancy test. Consider ectopic pregnancy. If pregnancy confirmed, woman should contact their doctor. Concomitant use with EC containing levonorgestrel not recommended. Does not contraindicate the continued use of regular hormonal contraception but reliable barrier method should be used until next menstrual period. Not recommended in severe asthma treated by oral corticosteroids. Concomitant use of CYP3A4 inducers [e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John’s wort), rifampicin, rifabutin, griseofulvin, efavirenz, nevirapine] not recommended (may decrease efficacy of ellaOne). Long term use of ritonavir not recommended. Not recommended for women who have used enzyme-inducing drugs in the past 4 weeks. Non-hormonal emergency contraception (i.e. a copper intrauterine device (Cu-IUD)) should be considered. Contains lactose. FERTILITY, PREGNANCY AND LACTATION: Not intended for use during existing or suspected pregnancy. Limited human data does not suggest safety concern. Does not interrupt existing pregnancy. No teratogenic potential was observed; animal data insufficient with regard to reproduction toxicity. Marketing Authorisation Holder maintains a pregnancy registry (www.hra-pregnancy-registry.com) to monitor outcomes of pregnancy in women exposed to ellaOne®. Patients and health care providers are encouraged to report any exposure. Ulipristal acetate is excreted in human breast milk; breastfeeding is not recommended for one week after intake. Breast milk should be expressed and discarded. A rapid return of fertility is likely following ellaOne use; regular contraception should be continued or initiated as soon as possible; subsequent acts of intercourse should be protected by reliable barrier method until next menstrual period. UNDESIRABLE EFFECTS: Always consult the SmPC before prescribing. Only the most common side effects and those which are rare but may be serious are listed below. Most commonly reported adverse reactions: headache, nausea, abdominal pain and dysmenorrhea. Common (≥1/100 to <1/10): mood disorders, dizziness, vomiting, abdominal discomfort, myalgia, back pain, pelvic pain, breast tenderness and fatigue. Rare (≥1/10,000 to <1/1,000): ruptured ovarian cyst. RETAIL PRICE: ellaOne 30 mg single film-coated tablet blister pack; € 35. MARKETING AUTHORISATION HOLDER: Laboratoire HRA Pharma, 15, rue Béranger, F-75003 Paris, France. Marketed in Ireland by: HRA Pharma UK & Ireland Limited, Haines House, 21 John Street, Bloomsbury, London, WC1N 2BF MARKETING AUTHORISATION NUMBER(S): EU/1/09/522/003. LEGAL CATEGORY: Medicinal product not subject to medical prescription. Date of last revision of text: October 2018 Adverse events should be reported. Reporting forms can be found at www.hpra.ie or email: medsafety@hpra.ie. Adverse events should also be reported to HRA Pharma UK & Ireland limited on Freephone: 1800 812 984 or email med.info.ie@hra-pharma.com


News HPRA engage in ‘benchmarking’ with European partners to deliver better outcomes for patients The HPRA received an assessment rating of 4.5 (out of 5) following participation for the first time in the Benchmarking of European Medicines Agencies (BEMA) programme. BEMA “aims to contribute to the development of a world-class pharmaceutical regulatory system across Europe, based on a network of agencies consistently employing recognised best practice.” The overall rating received by the HPRA is described in regulator’s annual review as “excellent”. According to Dr Lorraine Nolan, Chief Executive of the HPRA, 2017 was another significant year for the organisation. In addition to all areas and departments contributing to the delivery of a sizeable schedule of work, the HPRA’s performance in the BEMA programme validates its commitment to operating to the highest possible standards in delivering on its public health remit. “As a regulator, external recognition of the effectiveness of our operating procedures and standards clearly endorses our strategic commitment to and investment in these areas. The confirmation by the FDA of the equivalency of our systems in relation to GMP inspections is a hugely significant development and we look forward to shortly participating as a recognised country under the US/EU mutual recognition agreement. Also during 2017, we received an excellent overall rating of 4.5 (out of 5) through BEMA … The feedback and learnings from our BEMA audit will continue to drive our ambition to deliver the best possible outcomes for patients and members of the public. “Investment in our internal capabilities and technical expertise was a key priority in 2017 and is a core tenet of our strategic plan. New and innovative medicines and medical devices are constantly emerging and while this presents challenges to us a regulator, it is also an opportunity for the HPRA to further enhance our specialist innovation supports. Throughout 2017, there was a focus on developing and attracting expertise

in the areas of software, analytics and new fields of clinical interest. “Also from last year, we are particularly proud of our participation in a number of new engagement platforms that enable us to work more directly and fulsomely with patients and patient representatives. This included participating as an education partner in the first nationally developed patient education programme which was developed by the Irish Platform for Patient Organisations, Science & Industry (IPPOSI).” Looking forward, according to Dr. Nolan, the HPRA is ever conscious that it faces a range of opportunities and indeed challenges in the coming years in addition to its existing and extensive work programmes: “Our investment in developing internal capabilities and resources, our commitment to patient and broader stakeholder engagement, and our focus on supporting innovation, positions us well as we continue on our journey to positioning the HPRA as a regulator of the future.” The report from the Chief Executive also states that the HPRA was “centrally involved” in the first ever public hearing at the European Medicines Agency held in September, which related to continuing concerns around the dispensing and prescribing of sodium valproate, a known teratogenic medicine that has caused disability and malformation in up to 400 Irish children over the span of 45 years.

The HPRA was centrally involved in the first ever public hearing at the European Medicines Agency

Dr Lorraine Nolan, chief executive of the HPRA

Also of note in the report was the HPRA’s focus on minimising the entry of illegal substances and medicines into the Irish supply chain. Operation Pangea, now in its tenth year, took place in September, and was led by the HPRA in partnership with Revenue’s Customs Service and An Garda Síochána. The operation resulted in a threefold annual increase in the detention of illegal prescription medicines, with 200,000 units seized during the operation. The report outlines how Ireland, along with eighteen other member states, submitted proposals to European Council in respect of the relocation of the European Medicines Agency (EMA), following Britain’s exit from the European Union (Brexit). Amsterdam ultimately won the bid, but the process revealed the capabilities within the Irish regulatory system. The report states:

“Although Dublin was not the chosen location, the preparation of the proposal, the strength of which was recognised by numerous stakeholders, was a unique opportunity to showcase the many strengths of Ireland in relation to the wider life sciences sector, our access to scientific talent and the strong regulatory environment that has been established by the HPRA. It was a great pleasure to work with our Government colleagues on this project, which was of significant strategic importance from the perspective of public health and promoting Ireland’s economic interests and reputation internationally.” The report also outlines that a request from the Department of Health led to the HPRA adopting a role in the national coordination of medicines shortages following a review it convened under its Medication Safety Forum.

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Real Deal Conference Community pharmacists get lessons on how to grow their business at Real Deal Conference 2018 A large number of community pharmacists were in attendance at the Real Deal 2018 conference which showcased the potential of small- and medium-sized enterprises (SMEs) in Ireland. Attendees heard how these businesses have “huge” potential as employers and that private investors with the right skills and knowledge can help to grow a small business. The iconic event, organised by FitzgeraldPower Chartered Accountants, Renatus Capital Partners, law firm Byrne Wallace, and the Times and the Times on Sunday, was attended by pharmacists and other business owners from all over Ireland. Stuart Fitzgerald is the director of FitzgeraldPower and has considerable experience in the pharmacy and food and beverage SME sectors. Speaking to Irish Pharmacy News on the day, Fitzgerald shared that pharmacy businesses can benefit from the input of private investors. “Having a knowledgeable shareholder

on-board can really drive the business forward, and private investors have the skills to make sure the business achieves its potential.” Management Buy-ins/buy-outs The categories focused on critical strategic decisions faced by SMEs with the aim of

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educating and de-mystifying the options available in terms of capital. Tony McEntee is the CEO of Sam McCauley Chemists. He explained how he used experience gained in other businesses to lead a new era for McCauley’s through management buy-in (MBI), and with the help of funding from private investors,

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grew further what was already a great business. McEntee told attendees that “the biggest thing is that you build the business with openness and honesty: there is no agenda, other than the agenda, which is to grow the business.” The advice for anyone going through the MBO/MBI process is to

1. CEO of Sam McCauley’s Chemist, Tony McEntee 2. Rory O’Donnell, President, Pharmaceutical Society of Ireland 3. Pharmacists Joseph Haire and Patrick McCormack 4. Panel discussion at the Real Deal 2018 event 5. Jason Doherty from Hickey’s pharmacy, Rush with Oonagh O’Hagen from Meaghers 6. Joe O’Hare, pharmacist with Karen Ahern and Fergus McCauley from IQVIA 7. Brian Tynan, Phelans Pharmacy, Waterford along with Barry Brennan from Brennans’s Pharmacy in Tramore 8. Conall Lavery from RWA along with Kilian McGreal, pharmacist at McGreals Pharmacy in Blessington 9. Noel Winters, Corporate Finance Director and Stuart Fitzgerald, Directors at Fitzgerald Power chartered accountants

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Clonfolic 2018-ADV-FOL-064H_297x210mm Adv_FA.pdf

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Real Deal Conference keep the focus on the business and to focus on culture, and to challenge the “sacred cows” of management, with a view to opening up channels within the business that can lead to unforeseen growth. MBO/MBIs can bring opportunities for business owners wanting to retire, but they can also be fraught with difficulties due to conflicting stakeholder interests and, in a lot of cases, it is the first time the management team may have gone through such a process. They are a good option for owner/vendors who want to retire and who want to provide the current management team with an opportunity to take part in the future growth of the business. However, navigating through the MBOs can be considered complex due to conflicting stakeholder interests. Involving management in the

process with bonus and ownership incentives brings “enlightened self-interest” but McEntee cautions that everyone involved needs to keep an eye on the day-today running of the business throughout the process. Succession Planning Achieving an effective succession is one of the most difficult tasks facing many companies and family businesses need a well-thought out and executed plan for succession, ensuring a smooth transition to the next generation. Often the creation of a single entrepreneur, passing a god business to the next generation can put a strain of families. Caroline Keeling is the CEO of one of Ireland’s largest fresh produce companies, Keelings. She spoke to the crowd about succession planning and doing business within the family, and

explained how Keelings has been passed down successfully through three generations. She also shared how input from shareholders Chiquitta in the 1980s was “very successful” at the time and that it “massively expanded the company’s thinking and professionalism”. External input from shareholders can shed light on better ways of doing things, and can put the business on the right track, because “having a shareholder makes you think about things you might not necessarily do.” Keeling explained that in order to run a family business successfully, trust between all parties is key. Funding for Growth David Maxwell is the managing director of Mexican fast casual food brand Boojum, a chain of fast casual Mexican food restaurants that has gone from strength to strength since

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Maxwell and partners acquired it as part of a management buy-in in 2015. “It would not have been possible without the input of Renatus Capital Partners and it has been a very successful move, from everyone’s point of view.” Maxwell told the delegation that the business has grown from five stores to 17 and that everyone involved knew from quite early on that “we had something special with Boojum.” The company, which targets a core market of young professionals and students aged 18 to 40, has gone from strength to strength and now has outlets in Belfast, Dublin, Galway, Limerick and Cork, and they have plans to expand to the UK. Maxwell told attendees that getting the mix right between a motivated team and a positive and supportive capital partner can be the key to success.

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The Top 100 OTC Products

Pain relievers dominate top spots in Top 100 OTC Products list This month Irish Pharmacy News publishes our essential guide to the Top 100 OTC products. While we previously published a consumers’ list in August, this newly updated top 100 has been created in line with the OTC list that IPN published in previous years as a fair comparison. The information below is exclusive to IPN and has been complied by IQVIA, formerly IMS Health and Quintiles. IQVIA is the world’s leading information, service and technology company and is dedicated to improving health outcomes by using an evidence and data-based approach to healthcare.

The Irish Pharmacy News Top 100 uniquely compares the market performance over the past number of years. It is designed to take some of the strain away from the decision about which popular OTC products to stock, in order to boost profitability. The information is collected through distributor data from wholesalers, direct distribution by manufacturers and parallel importers on their sales into pharmacy, in terms of volume.

20 20 20 20 20 18 17 16 15 14

20 20 20 20 20 18 17 16 15 14

SOLPADEINE

1 1 1 1 1

AVEENO

NUROFEN PLUS

2 2 2 2 2

CETRINE ALLERGY 15 16 16 15 22

PANADOL EXTRA

3 3 4 4 7

DIORALYTE

16 15 18 18 20

CALPOL

4 5 5 5 6

NUROFEN COLD & FLU

17 17 17 19 15

PARALIEF

5 7 12 10 9

SUDAFED

18 19 19 17 18

NUROFEN CHILD

6 4 3 3 3

CALPOL SIX PLUS

19 26 24 24 28

PANADOL

20 21 21 20 14

NEXIUM CONTROL

21 29 39 76 0

CANESTEN

22 18 15 14 13

BUPLEX

23 46 0 0 0

SENOKOT

24 24 23 23 19

VOLTAROL

25 27 30 33 31

NUROFEN EXPRESS 7 6 6 6 8 CALCICHEW D3

8 10 10 12 44

NICORETTE

9 8 7 8 10

GAVISCON

10 9 8 7 5

GALFER

11 11 11 11 45

NUROFEN

12 12 9 9 4

LEMSIP

13 13 13 13 11

14 14 14 16 23

Please note that the six year comparison listed opposite, along with other comparisons with previous years, may include brands and categories whose classification may have changed over the four year period. The IPN top 100 OTC products and the method of its collation evolves with the pharmacy sector and in this context, comparisons with previous years are for indicative purposes only, using the data as printed in the IPN Top 100 in the year in question. As such, all comparative data publishes in this issue is designed to offer readers a broad reference tool rather than a like for like comparison.

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20 20 20 20 20 18 17 16 15 14 DULCO LAX

26 146 0

STREPSILS

0

0

20 20 20 20 20 18 17 16 15 14

20 20 20 20 20 18 17 16 15 14

BRUPRO

52 88 193 0 0

CB12

78 74 74 85 59

27 23 22 22 17

NICOTINELL

53 50 46 39 70

ZOVIRAX GLX

79 83 76 81 74

MOTILIUM

28 22 20 25 12

VERMOX

54 59 57 51 47

PHARMATON

80 308 0 0 0

BUTTERCUP BRONCHO

29 25 33 0 0

SUDAFED NASAL

55 60 59 60 62

SILCOCKS BASE OVE

81 82 79 119 0

DUPHALAC

30 20 26 0 0

DEEP HEAT

56 61 62 62 58

CELLUVISC

82 96 94 82 85

MAXILIEF

31 28 31 26 24

BONJELA

57 56 56 48 43

CERUMOL

83 78 75 74 191

OTRIVINE

32 32 28 31 26

VICKS

58 42 45 40 52

BEPANTHEN

84 76 84 80 77

PIRITON

33 31 35 29 30

ACTIFED

59 53 53 41 41

GAVISCON EXTRA STR

85 80 91 106 103

BENYLIN DAY NIGHT 34 34 41 46 60

LISTERINE

60 52 49 44 42

ELAVE

86 84 77 87 88

ZIRTEK

35 40 47 28 25

PARACETAMOL PZC 61 51 58 56 56

THERMACARE

87 73 78 89 94

TYROZETS

36 37 42 53 61

CODINEX

62 35 37 55 79

BEPANTISEPTIC

88 79 66 86 99

DAKTARIN

37 33 32 34 29

NIQUITIN

63 75 128 0 0

IDEOS

89 77 71 63 46

EASOFEN

38 45 29 32 34

E 45

64 62 54 43 38

ACIC

90 81 85 75 72

CONTOUR NEXT

39 43 48 61 83

CORTOPIN

65 36 50 45 57

DIFFLAM

40 39 36 35 32

BROLENE

66 66 64 64 49

BEECHAMS NIGHT NRS

91 100 114 113 118

INFATRINI

41 30 25 21 16

PANADOL ACTIFAST 67 68 61 59 54

BIO KULT

92 109 118 173 252

BEROCCA

42 38 34 30 21

PARACETAMOL A6D 68 58 27 27 36

LYCLEAR

93 85 90 97 120

SUDOCREM

43 93 0 0 0

SOLPA EXTRA

69 0

OPTREX

94 92 102 120 139

ONE TOUCH VERIO

44 55 65 140 226

RENNIE

70 65 60 57 48

OLBAS

95 105 110 100 90

SINUTAB

45 44 40 36 35

SAVLON

71 64 80 52 27

CAVILON

96 104 126 133 233

CORSODYL

46 47 51 42 37

BENYLIN DRY N/D

72 72 69 66 66

ANTI HIST ALLERGY

97 166 276 291 0

HYLO FORTE

47 63 81 130 225

PHARMATON KIDDI 73 314 0

ALFLOREX

98 134 185 232 280

IMODIUM

48 57 55 58 39

CYSTOPURIN

74 69 68 65 65

BENYLIN 4 FLU

99 87 72 70 67

ARTELAC

49 41 38 50 272

SEVEN SEAS C L O

75 71 73 67 51

PHENERGAN

100 103 115 94 87

CALDESENE

50 49 52 38 40

IMODIUM PLUS

76 70 67 69 80

FYBOGEL

51 48 44 37 33

ARRET

77 67 63 54 53

0

0

0

0

0

PHARMACYNEWSIRELAND.COM | 71


Feature

How pharmacists can help to protect skin during winter months

BY AMANDA PHELAN

PHARMACISTS are gearing up to help customers through the winter months by maintaining good health both for the body and the skin. Many of us know the value of protecting our skin from those cancer laden rays in summer, but for men and women, protecting your skin through winter is just as important. “During the winter our skin can become dry and cracked as a result of being exposed to the cold,” Boots pharmacist Susan O’Dwyer tells Irish Pharmacy News. “Keeping skin hydrated and moisturised is important in helping keep your skin as soft and supple as possible.” Experts advise this is the season to learn to efficiently ease your epidermis through the winter chill. Pharmacists are on hand with handy tips: “Make sure to get enough water to help keep you hydrated and wrap up well,” says Ms O’Dwyer. As well as your face, it’s important to remember the rest of your body as it can suffer in the harsher climate, especially hands and arms “Gloves provide great protection for hands which can be susceptible to chafing from wind,” says O’Dwyer. Some simple adjustments can keep us more winter proof, she says: “Using an effective emollient after bathing and whenever the skin feels itchy or dry is one of the best ways to keep your skin moisturised. If your skin is dry you may also benefit from switching to a non-soap cleanser.” Lips too can take a battering in the icy winds as our lips don’t have oil glands. This means they are susceptible to cracking and becoming painful in the colder weather. This can be remedied by applying good quality balms and moisturising products before they show signs of drying. And this is the season

Boots pharmacist Susan O'Dwyer

Denis O'Driscoll, Superintendent Pharmacist at LloydsPharmacy

where embarrassing cold sores, chapping and eczema are most likely to flare-up but the good news is there are plenty of good quality balms and ointments to help.

serum as these penetrate more deeply. Look for skin products containing hyaluronic acid as this is great for moisture; one molecule can hold up to 1,000 times its own weight in water.

Meanwhile, while we all know skin can get more dry and red during winter, a recent study has shed light on exactly why.

And scrub up, exfoliation is vital in winter to help slough off dry and dead skin cells and better protect the new ones. Stay away from harsh exfoliants, as those with beads may damage your skin. Instead, opt for more gentle choices, including a soft brush or silicone exfoliator to be kinder to your skin.

The Copenhagen study, published in the British Journal of Dermatology, shows the skin's natural moisturising factor (NMF) is diminished during winter, possibly because the cold disrupts the skin's ability to produce natural moisturisers. This could be a valuable insight into what’s behind the millions of people who suffer from dry skin in the winter chill, that often develops into permanent skin conditions like atopic eczema and rosacea. Solutions to combating winter skin include switching up your skin routine as, contrary to popular conceptions, moisturisers don’t actually moisturise, but just help seal in the moisture your skin already has. So with this in mind, it’s a good time to introduce a

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Many pharmacies are displaying leaflets and advice on coping with winter. For example, at LloydsPharmacy the new health and wellness campaign Best Version of You stresses the value of being prepared for the seasonal change. “The campaign highlights the importance of preparing for winter at a time of year when staying healthy is most demanding,” says Denis O’Driscoll, Superintendent Pharmacist at LloydsPharmacy. “During winter, harsh weather

can weaken our immune systems. Incidences of seasonal illness, and viruses such as flu, rise in winter and can easily spread,” he says. “Harsh weather can also aggravate our skin and chronic diseases such as asthma. “ The Copenhagen researchers agree, and their study of 80 volunteers found NMF was lower in the winter, but higher in the summer. They also noted through microscopy that the skin shrinks, changing its surface. And the presence of nano-sized particles on the skin surface actually increased and this has been associated with dermatitis and the red, scratchy appearance of skin in cold weather. Cold weather, especially cold wind combined with increased use of central heating has a drying effect on the skin. Even those with ‘normal’ skin will notice this change, perhaps experiencing red cheeks, taut skin and cracked lips. For people with dry skin conditions, the change can often be enough to cause increased incidences of flare-ups.


Doublebase™ Emollient Gel Fine tuned for the management of dry skin and conditions such as eczema or psoriasis

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Recommend Doublebase Emollient Gel to soften, moisturise and protect dry skin and conditions such as eczema or psoriasis. Doublebase Emollient Gel Therapeutic ingredients: Isopropyl myristate 15% w/w, liquid paraffin 15% w/w. Presentation: White opaque gel. Uses: Highly moisturising and protective hydrating gel for regular and frequent use in the management of dry skin conditions such as eczema, psoriasis or ichthyosis. Directions: Adults, the elderly, infants and children: Apply directly to dry skin as often as needed. It may also be applied before washing, showering or bathing to prevent further drying of the skin. Contra-indications, warnings, side effects etc: Do not use if sensitive to any of the ingredients. In the rare event of a reaction stop treatment. Care should be taken as emollients which soak into clothing, pyjamas, bedlinen etc. can increase the flammability of these items. Patients should avoid these materials coming into contact with naked flames or lit

cigarettes etc. As a precaution, dressings and clothing, etc., should be changed frequently and laundered thoroughly. Ingredients: Isopropyl myristate, liquid paraffin, glycerol, carbomer, sorbitan laurate, trolamine, phenoxyethanol, purified water. Pack sizes: 100g tube and 250g pump pack. Legal category: Class I medical device. Further information is available from the manufacturer: Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR, UK. Date of preparation: December 2017. ‘Doublebase’ is a trademark. 11mm Adverse events should be reported to Dermal.

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Feature showing these are proven to hydrate dry air for a healthier environment. Many leading pharmacies now carry good quality versions that deliver hygienic, even humidification in winter and high-velocity air to cool you in summer. Key tips for a good winter skin regime include:  Maintain healthy eating and diet  Eat loads of vegetables and fruit (up to seven portions a day is now recommended)  Drink plenty of fluids (At least 1.5 or 2 litres of water a day)  Keep skin supple and moisturised  Avoid very hot showers or baths on the face  Exercise regularly

LloydsPharmacy staff have launched the Best Version of You campaign

And experts advise us to avoid the tempting proposition of a piping hot bath or shower, as, particularly for our face, lukewarm temperatures are best.

 Get plenty of sleep

Other key tips for blooming winter skin include hydration, overnight moisturising and of course eating good food and drinking good quality water even

though it feels like the perfect time to sip hot cocoa or coffee. As well, it can be good to invest in a humidifier, with research

 Use a disposable tissue and dispense with it correctly after use  Wash hands after sneezing/ coughing and use a hand sanitiser if necessary

News Migraine relief now available without prescription at pharmacies nationwide Irish people who suffer from migraine will, for the first time, be able to access a highly effective treatment, without prescription, directly from their pharmacy. This follows a reclassification of the medication sumatriptan which now allows it to be made available without prescription, a change which had long been called for by migraine sufferers and by the Irish Pharmacy Union (IPU). Welcoming the move, President of the IPU Daragh Connolly said, “Migraine is a severe neurological condition that affects 15% of the world’s population. It is estimated that as many as half a million Irish people suffer from migraine. The symptoms can be extremely debilitating for those who

suffer from migraine and we warmly welcome the fact that pharmacists will now be able to help sufferers get relief by providing this highly effective medication. “Treating migraine as soon as it appears is often the key to effectively managing a migraine. When sumatriptan was prescription only, people were often unable to obtain it when it was most needed. Pharmacies are the most accessible component of our healthcare system and making sumatriptan directly available from pharmacists will greatly

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increase our patients’ abilities to get the treatment they need when they need it.” The Irish Pharmacy Union is urging anyone who is concerned that they may be experiencing the early symptoms of a migraine to visit their local community pharmacy for advice. The Migraine Association of Ireland has also welcomed the decision. CEO, Patrick Little, said, “The increased access to appropriate migraine medication and advice will be a significant benefit to migraine patients in Ireland. As a migraine can strike at practically any time,

it is reassuring to know that there is now a treatment available without prescription, from community pharmacies nationwide. “If people do feel they are suffering from migraine, then they should consult with their GP or community pharmacist in the first instance to ensure they identify their triggers and they are receiving appropriate and effective medication. For advice and support on managing your migraines we would encourage people to call our Information and Support Line on 1850 200 378.”


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News HSE confirms HPV vaccine 65% provisional uptake rate The HSE has confirmed the latest provisional uptake rate for the HPV Vaccine at 65%, marking an increase of 15% in over a year, with two in every three Irish girls now protected. priority for me, and subject to a favourable recommendation from HIQA, the Government will seek to extend this vaccine universally as a priority. I want to be unequivocal again in saying that the HPV vaccine protects young people's lives and I urge parents to vaccinate their daughters this autumn." Dr Sean Denyer, Interim Head of the HSE National Immunisation Office described the 15% increase in the uptake rate as “extremely encouraging.”

Health Minister, Simon Harris

The schedule involves national and regional radio advertising, along regional newspaper advertising, social media promotion, digital search advertising and organic social media posts on Facebook and Twitter.

true of cervical cancer. We are lucky to have a vaccine that can potentially prevent 70% of cervical cancers, and I am very pleased to say that our increased provisional uptake figures last year have been internationally recognised. This very welcome increase reflects the huge amount of work being done across the medical community, including school vaccination teams, GPs and pharmacists, to provide accurate and trusted information.

Minister for Health Simon Harris TD said "Prevention is better than cure, and this is especially

“Extending the national immunisation schedule to include HPV vaccination of boys is a

With school vaccination teams now in second level schools administering the vaccine to first year girls, the latest phase of the HSE Vaccine Information Campaign is already underway.

“We know this vaccine is safe; we know it works and we are now seeing the majority of parents throughout the country move to protect their daughters. We understood that parents wanted to do the right thing for their children, so we set out to provide them with scientifically and evidence based information. “We encouraged them to speak directly with the school vaccination teams, their local GPs and their local pharmacists. We provided a trusted source of information through hpv.ie. Clearly they have responded and now as we move into a new school year with a new group of first year girls, we

are reaching out to a new set of parents, inviting them to access information through those same trust sources and encouraging them to ensure their daughters are vaccinated. We are also reminding parents that a catch up facility is available so anyone who may have hesitated previously can contact our schools teams and get their daughter vaccinated.” The approach taken by the HSE (in co operation with partner agencies and bodies) in successfully addressing the significant drop in uptake rates has been commended by the World Health Organization. The WHO are encourages countries experiencing similar issues to consider adopting a broad collaborative approach. The WHO Regional Office for Europe has also invited Irish HPV vaccine advocate Laura Brennan to participate in their forthcoming International Day of the Girl campaign. The WHO is also acknowledging this Irish success by issuing a news release acknowledging the work that has been carried out in Ireland and Denmark in addressing the sharp downfall in uptake rates.

Haven Pharmacy supports knitting fundraising campaign Two of Ireland’s best known actors - Geraldine Plunkett and Mary McEvoy, mother and daughter respectively in Glenroe - have launched a fundraising campaign for the Beaumont Hospital Foundation. Knitivity, supported by Haven Pharmacy and the Irish Countrywomen’s Association (ICA), invites people countrywide to get ‘knitting for good’ by creating a range of Christmas-themed patterns that make great gift items and stocking fillers. Once knit, the Foundation asks people to sell their creations locally; to return them by freepost for sale through the hospital or to drop them into any Haven Pharmacy countrywide where they will be sold to fund equipment that improves patient care at Beaumont Hospital. The Knitivity range features projects for both the experienced and the novice knitter and the charity is asking primary school teachers to get their pupils involved by knitting in support of the hospital.

The 2018 pattern booklet includes patterns for tea cosies, door wreaths and elves as well as simpler items such as mug cosies, festive lapel pins and a miniature hat and scarf sets for decorating gift bottles. The prices range from ¤5 to ¤40 and the completed knits are sold in attractive branded gift bags, accompanied by an ID card (giving the name and county of origin of the item’s creator) to acknowledge and personalise their contribution. The patterns are available for download at www.beaumontfundraising.ie. They are also available in a printed booklet which can be posted to people who register on the charity’s website and available from all Haven Pharmacies countrywide. The starter pack includes a pattern

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booklet, sew-on fabric Knitivity labels to brand the knitted items, ID cards for knitters to provide their name and county of origin and printed freepost return labels. Paddy Delaney, managing director, Beaumont Hospital Foundation, said: “It’s been wonderful to see the enthusiasm that this has generated amongst the nation’s knitting community. “We are encouraging knitters to sell their items locally at Christmas fairs and other festive events and remit the funds to the hospital. “Alternatively, they can return their completed work to us here in Beaumont or to any Haven Pharmacy to save on postage. “The festive items make wonderful gifts and stocking fillers and Haven Pharmacies will remit 100 percent of the sales price to us.”

Actress Mary McEvoy is supporting the fundraising campaign If you would like to get involved you can register to receive a Knitivity pack at www.beaumontfundraising.ie; by phone on 01–8092457 or you can pick one up in your local Haven Pharmacy (see havenphamacy.ie).


Clinical Profiles FDA APPROVES KYPROLISÂŽ (CARFILZOMIB) ONCE-WEEKLY 70 MG/ M2 IN COMBINATION WITH DEXAMETHASONE (KD70) FOR PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

response rates (ORR), with a comparable safety profile, versus twice-weekly KYPROLIS administered at a dose of 27 mg/m2 in combination with dexamethasone (twiceweekly Kd27). KYPROLIS is not approved for twice-weekly 27 mg/m2 administration in combination with dexamethasone alone.

Amgen (NASDAQ:AMGN) has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLISÂŽ (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (onceweekly Kd70) for patients with relapsed or refractory multiple myeloma. The approval is based on data from the Phase 3 A.R.R.O.W. trial, which demonstrated that KYPROLIS administered once-weekly at 70 mg/m2with dexamethasone achieved superior progressionfree survival (PFS) and overall

"In the fight against multiple myeloma, we are committed to continued evidence generation and innovation to serve patients. KYPROLIS now offers patients with relapsed or refractory multiple myeloma the option of a more convenient dosing regimen that provides better outcomes with a comparable safety profile," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We're pleased that the FDA has recognised the importance of bringing more treatment options to cancer patients more quickly through its pilot programs and proud to participate with this KYPROLIS data."

The FDA reviewed the application under its Oncology Center of Excellence RealTime Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. The FDA approved the application in just over one month after the final component of the application was submitted. "While great progress has been made in the last decade, multiple myeloma remains an incurable disease characterized by a recurring pattern of remission and relapse, and it is important that patients have treatment options that meet their individual needs," said David S. Siegel, M.D., Ph.D., chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center. "The availability of a more convenient once-weekly dosing regimen, with superior efficacy, comparable safety, and longer duration of therapy

versus the twice-weekly regimen studied in the trial could allow patients to spend more time outside of the infusion center." A.R.R.O.W. included 478 patients with relapsed and refractory multiple myeloma who received at least two or three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Patients in the trial treated with once-weekly Kd70 achieved a statistically significant 3.7 month improvement in PFS compared to the Kd27 twice-weekly regimen (median PFS 11.2 months for once-weekly Kd70 versus 7.6 months for twiceweekly Kd27; HR=0.69; 95 percent CI: 0.54-0.88; one-sided p=0.0014).The ORR in patients treated with onceweekly Kd70 was 62.9 percent versus 40.8 percent for those treated with twice-weekly Kd27 (p<0.0001). In addition, 7.1 percent had complete responses or better in the once-weekly arm versus 1.7 percent in the twice-weekly arm in this refractory patient population.

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